[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiotoxicity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiotoxicity":24},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,42,73,126,153,181,214,241,266,295,323,350,374,402,431,463,491,520,544,569,605,638,661,685,710],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100644417","development-of-a-pharmacogenomic-panel-for-early-detection-of-chemotherapy--and-immunotherapy-induced-cardiotoxicity-100644417",false,"NCT07663357","Development of a Pharmacogenomic Panel for Early Detection of Chemotherapy- and Immunotherapy-Induced Cardiotoxicity.","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of breast cancer who are scheduled to initiate treatment with anthracyclines and\u002For HER2-targeted therapies (anti-HER2 therapies).\n\nExclusion Criteria:\n\n* Patients with a left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Patients who have undergone chemotherapy and\u002For radiotherapy within the previous year;\n* Patients with chronic kidney disease and a glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m²;\n* Patients with uncontrolled hypertension;\n* Patients with complex congenital heart disease.","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","To evaluate the use of a pharmacogenetic and pharmacoepigenetic panel for predicting chemotherapy- and immunotherapy-induced cardiotoxicity in cancer patients.",[24],"Cardiotoxicity",[26,24,27,28],"oncology","pharmacogenomics","epigenomics","RECRUITING","2026-06-17",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":33},"2026-05-11",{"date":37,"type":20},"2029-12-30",{"name":39,"class":40},"Beneficência Portuguesa de São Paulo","OTHER",6,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100641249","phase-2-the-cardioprotect-trial-100641249","NCT07654426","The CARDIOPROTECT Trial","A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial","Inclusion Criteria:\n\n* Participants must have histologically confirmed diffuse large B-cell lymphoma, histologically transformed large B cell lymphoma from a prior indolent lymphoma, or other high-grade B-cell lymphoma for which R-CHOP or pola-R-CHP are planned. Any cancer stage is permitted.\n* Participants must not have received any prior chemotherapy for this malignancy. Pre-phase steroids are allowed. Prior treatment for a different malignancy is allowed, including prior treatment for indolent lymphoma.\n* Age ≥18 years. Diffuse large B cell lymphoma is rare in participants \\\u003C18 years of age. The prevalence of HF prior to chemotherapy is also exceedingly rare in participants \\\u003C18 years of age; therefore, participants \\\u003C18 years of age are excluded from this study.\n* Participants must have ONE or more of the following risk factors for HF events with anthracycline-containing chemotherapy\n\n  1. LVEF 30-50% on most recent echocardiogram with or without HF history\n  2. LVEF 50% with a history of HF (i.e. HF with improved EF or HF with preserved EF).\n  3. History of anthracycline exposure for different malignancy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Because dexrazoxane as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) Class III or IV exertional dyspnea. The symptoms should be attributed to HF and not due to lymphoma, anemia, arthritis or other causes per the assessment of the treating clinician or study investigator. NYHA Class III defined as: \"Marked limitations with less than ordinary activity such as walking short distances or climbing a few stairs\" and NYHA Class IV defined as: \"Inability to carry out any activity without discomfort. Symptoms are present at rest and if any physical activity is undertaken the symptoms are increased.\" (see Appendix A for NYHA Classification).\n* LVEF \\\u003C30% on most recent echocardiogram. Patients with prior LVEF \\\u003C30% with improvement to \\>30% on most recent echocardiogram are eligible.\n* Meeting criteria for frailty according to the simplified geriatric assessment (see Appendix A for the simplified geriatric assessment criteria).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.\n* Presence of central nervous system involvement\n* Presence of concurrent genetic rearrangements of the MYC and BCL2 genes, so called \"double-hit\" large-cell lymphoma who are not deemed eligible for intensified induction chemotherapy such as dose adjusted EPOCH-R by their treating physician can be enrolled\n* Ineligible for R-CHOP or pola-R-CHP because of liver disease per institutional policies\n* Patients with planned dose reductions from the first cycle ie R-mini-CHOP will be excluded\n* There are no contraindicated medications. Caution and monitoring are advised with medications that can cause myelosuppression.\n* Patients with positive Hepatitis B core antibody can be enrolled if they have negative viral load and can be maintained on antiviral prophylaxis\n* Patients with HIV can be enrolled if they have anti-retroviral therapy options without drug-drug interactions with the cancer treatment, agree to take anti-retroviral therapy and do not have uncontrolled opportunistic infections.\n* Pregnant women are excluded from this study because dexrazoxane and liposomal doxorubicin are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dexrazoxane and liposomal doxorubicin, breastfeeding should be discontinued if the mother is treated with dexrazoxane and liposomal doxorubicin. These potential risks may also apply to other agents used in this study.\n* Eligibility for observational arm of the study. The above inclusion and exclusion criteria are for the randomized trial. Patients who meet the inclusion criteria but have one or more exclusion criterion are eligible to participate in the observational arm of the study. In addition, patients who meet all eligibility criteria for the randomized trial but decline participation in the randomized trial are also eligible to participate in the observational arm of the study.",{"count":50,"type":20},60,"INTERVENTIONAL",[53],"PHASE2","This trial is to evaluate if dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart failure events in participants with diffuse large B-cell lymphoma (DLBCL) undergoing either standard of care R-CHOP or pola-R-CHP treatment regiments.\n\nThe names of the study drugs involved in this study are:\n\n* Dexrazoxane (a type of Topoisomerase II Inhibitor)\n* Liposomal Doxorubicin (a type of Topoisomerase II Inhibitor)\n* Standard of care R-CHOP treatment regimen (Cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab)\n* Standard of care pola-R-CHP treatment regimen: Cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab",[56,24,57],"Diffuse Large B-cell Lymphoma (DLBCL)","Lymphoma",[56,59,24,57,60,61,62],"High Risk for Heart Failure Events","Stage B Heart Failure","Stage C Heart Failure","Left ventricular ejection fraction (LVEF) decline","NOT_YET_RECRUITING","2026-06-12",{"date":30,"type":33},{"date":67,"type":20},"2026-10-02",{"date":69,"type":20},"2035-12-31",{"name":71,"class":40},"Beth Israel Deaconess Medical Center",1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":84,"conditions":85,"keywords":100,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100569808","ai-enabled-direct-from-ecg-ejection-fraction-ef-severity-assessment-using-cor-ecg-wearable-monitor-100569808","NCT06699056","AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor","AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using COR ECG Wearable Monitor","EFACT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able and eligible to wear a Holter monitor\n\nExclusion Criteria:\n\n* Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1\n* Any condition that, in the investigator's opinion, could interfere with compliance with the study protocol or pose a safety risk to the participant\n* History of poor tolerance or severe skin reactions to ECG adhesive materials",true,{"count":83,"type":20},2000,"This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood.\n\nIn this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.",[86,87,88,89,90,91,92,93,24,94,95,96,97,98,99],"Ventricular Ejection Fraction","LVF","LV Dysfunction","Atrial Enlargement","Conduction Defect","Heart Failure","Valvular Heart Disease","Ischemic Heart Disease","Myocardial Infarction","Dilated Cardiomyopathy","HFrEF - Heart Failure With Reduced Ejection Fraction","HFpEF - Heart Failure With Preserved Ejection Fraction","Syncope","Remodeling, Cardiac",[101,102,103,104,105,106,107,88,108,109,110,111,112,113,89,114],"ECG Patch","LVEF","Holter","ECG Wearable","COR","Atrial Conduction","ECG Biomarker","SaMD","Clinical Decision Support","ECG","EF Severity","Ejection Fraction","AI","Electrical Remodeling","2026-05-28",{"date":117,"type":33},"2026-06-01",{"date":119,"type":33},"2024-11-21",{"date":121,"type":20},"2027-11-15",{"name":123,"class":124},"Peerbridge Health, Inc","INDUSTRY",8,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":133,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":51,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100517902","phase-2-a-study-of-blood-pressure-control-during-cancer-treatment-100517902","NCT06023576","A Study of Blood Pressure Control During Cancer Treatment","Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Female assigned at birth\n* Biopsy proven breast cancer (stage I-IV)\n* Treatment with therapy anthracycline-based chemo (with or without HER2-targeted therapy), with \\>\u002F= 2 cycles of anthracycline chemotherapy planned.\n* SBP ≥130 mm Hg\n* Willing and able to comply with the requirements of the protocol.\n* Participant must have and be willing to use their bluetooth enabled wifi or cellular mobile device\n* (For participants in the CPET cohort): Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria:\n\n  * Achieving a plateau oxygen consumption, concurrent with an increase in power output;\n  * A respiratory exchange ratio ≥ 1.10;\n  * Attainment of maximal predicted heart rate, as defined by a peak heart rate within 10bpm of the age predicted maximal heart rate (220 - Age\\[years\\]);\n  * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.\n\nExclusion Criteria:\n\n* eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2 (based upon Cockcroft-Gault, etc.)\n* Individuals with arm circumference too large to allow accurate BP measurement with available BP devices\n* Inability to accurately measure blood pressure in at least one arm (e.g., bilateral upper extremity lymphedema)\n* Cardiac comorbidity, including any of the following:\n\n  * Acute coronary syndrome within 3 months prior to randomization.\n  * Symptomatic heart failure (NYHA class III\u002FIV) within past 6 months\n  * History of stroke\n  * Cardiac transplantation\n* Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or adhere to study interventions\n* (For participants in the CPET cohort): Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:\n\n  * Acute myocardial infarction (within 30 days of any planned study procedures),\n  * Unstable angina\n  * Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,\n  * Symptomatic severe aortic stenosis\n  * Recurrent syncope\n  * Active endocarditis\n  * Acute myocarditis or pericarditis\n  * Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)\n  * Thrombosis of lower extremities (within 3 months of any planned study procedures)\n  * Suspected dissecting aneurysm\n  * Uncontrolled asthma\n  * Pulmonary edema\n  * Room air desaturation at rest ≤85%\n  * Respiratory failure\n  * Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)\n  * Mental impairment leading to inability to cooperate.","FEMALE",{"count":135,"type":20},130,[53],"The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer.\n\nThe PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.",[139,24],"Breast Cancer",[141,142],"Blood pressure","23-159","2026-05-13",{"date":145,"type":33},"2026-05-14",{"date":147,"type":33},"2023-08-18",{"date":149,"type":20},"2029-05-30",{"name":151,"class":40},"Memorial Sloan Kettering Cancer Center",7,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":133,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":177,"leadSponsor":179,"locationsCount":72},"100638118","cardiac-side-effects-of-systemic-therapy-in-early-stage-breast-cancer-100638118","NCT07588425","Cardiac Side Effects of Systemic Therapy in Early-Stage Breast Cancer","Prospective and Molecular Biomarker-Based Evaluation of Cardiac Side Effects in Patients With Early-Stage Breast Cancer Receiving Systemic Therapy: A Single-Center Observational Cohort Study","C-BREAST-01","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of breast cancer\n* Stage I, II, or III disease\n* Planned neoadjuvant or adjuvant chemotherapy and\u002For HER2-targeted systemic therapy\n* Baseline transthoracic echocardiographic left ventricular ejection fraction (LVEF) ≥ 50%\n* Age ≥ 18 years\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Metastatic (Stage IV) breast cancer\n* Pre-existing heart failure or clinically significant cardiac disease\n* Prior exposure to chemotherapy or other cardiotoxic systemic therapy\n* Concurrent active malignancy other than breast cancer\n* Inability or unwillingness to comply with the planned follow-up and assessment schedule",{"count":162,"type":20},100,"The goal of this observational study is to evaluate cardiac side effects in women with early-stage breast cancer who receive systemic chemotherapy and\u002For anti-HER2 therapy as part of their standard cancer care.\n\nThe main questions it aims to answer are:\n\nCan changes in Global Longitudinal Strain (GLS) on echocardiography detect early cardiac dysfunction before a drop in left ventricular ejection fraction (LVEF) becomes apparent? Are changes in circulating microRNA levels in the blood associated with early cardiac dysfunction during cancer treatment? Does cardiac dysfunction occur more frequently with anthracycline-containing chemotherapy compared to anthracycline-free regimens?\n\nParticipants already receiving standard chemotherapy and\u002For anti-HER2 therapy as part of their routine cancer care will undergo echocardiography (LVEF and GLS), provide blood samples for microRNA analysis, and complete quality of life questionnaires at four time points: before treatment (baseline), and at 3, 6, and 12 months after starting treatment.",[165,24,166],"Breast Cancer (Early Breast Cancer)","Cancer Therapy-Related Cardiac Dysfunction",[168,169,170,24,171,172,173],"Early-stage breast cancer","Anthracyclines","Anti-HER2 therapy","GLS","microRNA","Cardio-oncology","2026-05-10",{"date":145,"type":33},{"date":174,"type":20},{"date":178,"type":20},"2028-03-30",{"name":180,"class":40},"Fatih GURLER",{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":190,"studyType":21,"phases":4,"briefSummary":191,"conditions":192,"keywords":196,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":72},"100485269","global-cardio-oncology-registry-100485269","NCT05598879","Global Cardio Oncology Registry","G-COR","Inclusion Criteria:\n\n* New cardio-oncology consultation for breast cancer patients, or\n* New cardio-oncology consultation for Hodgkin's or non-Hodgkin's lymphoma patients, or\n* New cardio-oncology consultation for acute or chronic leukemia patients, or\n* New cardio-oncology consultation for multiple myeloma or AL amyloidosis, or\n* New cardio-oncology consultations for immune check-point inhibitors cardiac evaluation.\n* All patients have to be 18 years old or older\n\nExclusion Criteria:\n\n* Cardio-oncology patients who have previously had cardio-oncology evaluation and follow up by the investigators.\n* Minors less than 18 years old.\n* Inability or unwillingness to consent to participate",{"count":189,"type":20},5000,"24 Months","G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.",[139,193,194,24,195],"Hematologic Malignancy","Immune Checkpoint Inhibitor-Related Myocarditis","Cardiovascular Diseases",[197,198,199,200,201,202,203,204],"cardiotoxicity","Cancer related cardiovascular diseases","prospective registry","international collaboration","social determinants of health","health care disparities","real world data","cardiology-oncology team work","2026-05-07",{"date":207,"type":33},"2026-05-12",{"date":209,"type":33},"2022-07-01",{"date":211,"type":20},"2029-07-01",{"name":213,"class":40},"The Cleveland Clinic",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":51,"phases":223,"briefSummary":224,"conditions":225,"keywords":228,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":72},"100636937","phase-2-sotagliflozin-as-prevention-of-anthracycline-related-cardiotoxicity-100636937","NCT07572175","Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity","SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)","SPARTACUS","Inclusion Criteria\n\n* Patients ≥ 18 years\n* Newly diagnosed lymphoma\n* Scheduled to receive high-dose anthracycline (cumulative dose ≥ 300 mg\u002Fm2)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-3\n\nExclusion Criteria\n\n* Prior anthracycline treatment\n* Previous malignancy requiring any chemotherapy or radiotherapy\n* Previous treatment with SGLT2i (eg due to T2DM) or SGLT1\u002F2i\n* Previous heart failure (HF patients should already be on SGLT2i as per guidelines)\n* LVEF\\\u003C40% (even in the absence of HF):\n* Pregnancy or breastfeeding\n* Standard contraindication to MRI (claustrophobia, non-MRI compatible devices)",{"count":50,"type":20},[53],"This project aims to determine the benefits of the dual SGLT1\u002F2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.",[226,57,227,24],"Anthracycline-induced Cardiotoxicity","Chemotherapy",[229,230,197,231,232],"anthracycline","left ventricular dysfunction","SGLT inhibitors","prevention","2026-04-30",{"date":205,"type":33},{"date":236,"type":20},"2026-07",{"date":238,"type":20},"2029-10",{"name":240,"class":40},"Icahn School of Medicine at Mount Sinai",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":51,"phases":251,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":72},"100633584","serial-cardiac-magnetic-resonance-imaging-cmr-with-contrast-agents-and-biomarker-analysis-for-the-detection-of-cardiotoxicity-under-anthracycline-containing-cancer-therapy-100633584","NCT07528586","Serial Cardiac Magnetic Resonance Imaging (CMR) With Contrast Agents and Biomarker Analysis for the Detection of Cardiotoxicity Under Anthracycline-containing Cancer Therapy","Serial Cardiac Magnetic Resonance Imaging (CMR) With Contrast Agents and Biomarker Analysis for the Detection of Cardiotoxicity Under Anthracycline-containing Cancer Therapy - A Monocentric, Low Interventional Phase IV Pilot Study","CMR-Onko","Inclusion Criteria\n\n\\- Patients with a recommendation for antineoplastic therapy including at least four administrations of an anthracycline\n\nExclusion Criteria\n\n* Inability to provide informed consent\n* Prior administration of an anthracycline\n* Administration of cardiotoxic drugs within the last six months, such as:\n* High-dose cyclophosphamide (\\>1,000 mg\u002Fm² or \\>10 mg\u002Fkg)\n* HER2 inhibitors\n* VEGF inhibitors\n* BCR-ABL inhibitors\n* BRAF inhibitors\n* MEK inhibitors\n* Immune checkpoint inhibitors (CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors)\n* Planned invasive cardiac intervention during the study period\n* Cardiac involvement of an underlying disease, e.g. amyloidosis\n* Treatment with fewer than four administrations of anthracyclines\n* Treatment with a liposomal anthracycline formulation\n* Treatment in which anthracyclines are not administered in every chemotherapy cycle\n* Thoracic radiation involving the heart prior to anthracycline administration\n* Participation in another clinical study concurrently or within the last three months\n* Renal impairment with a GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m²\n* Patients in the perioperative phase of liver transplantation\n* Contraindications to cardiac magnetic resonance imaging, such as metallic implants (e.g. cardiac pacemaker)\n* Pregnancy or breastfeeding\n* Hypersensitivity or intolerance to gadolinium-based contrast agents\n* Vulnerable populations (individuals unable to protect their own interests, prisoners)",{"count":250,"type":20},93,[252],"NA","The goal of the trial is the early detection of cardiotoxicity in patients treated with anthracycline-based chemotherapy. Current diagnostics, such as troponin T, NT-pro-BNP, electrocardiogram, and echocardiography, are not able to identify early myocardial damage. Therefore, this study aims to identify early myocardial damage by using cardiac magnetic resonance imaging.\n\nThe primary endpoint of this study is the change in relaxation times in CMR before, during, and after therapy.\n\nFurthermore, the study analyzes:\n\n* other abnormal results in CMR\n* changes in troponin T and NT-pro-BNP\n* changes in global longitudinal strain in echocardiography and correlation with results of CMR\n* detection of new biomarkers in blood, urine, or stool",[24,226],[229,197,256],"cardiac magnetic resonance imaging","2026-04-07",{"date":259,"type":33},"2026-04-14",{"date":261,"type":33},"2026-03-04",{"date":263,"type":20},"2030-03",{"name":265,"class":40},"Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":51,"phases":276,"briefSummary":278,"conditions":279,"keywords":283,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":294},"100530181","phase-4-the-stop-med-ctrcd-trial-100530181","NCT06183437","The STOP-MED CTRCD Trial","A Multi-Centre Non-Inferiority Randomized Controlled Trial of STOPping Cardiac MEDications in Patients With Normalized Cancer Therapy Related Cardiac Dysfunction: The STOP-MED CTRCD Trial","STOP-MED CTRCD","Inclusion Criteria:\n\n* Adult patients (age ≥18 years) with cancer therapy completed more than 6 months prior (other than hormonal therapy) and no plan for further cancer treatments with potential risk for CTRCD.\n* Prior cancer therapy with anthracyclines and\u002F or HER2-targeted therapy.\n* Prior asymptomatic, moderate to severe CTRCD, defined using the ESC\u002FICOS criteria (MODERATE: ≥10% drop in LVEF from baseline to 40% to 49.9% OR \\\u003C10% drop to 40-49.9% with a reduction in GLS by \\>15% or new abnormal Troponin I\u002FT or NT-proBNP or SEVERE: new LVEF reduction to \\\u003C40% from normal baseline LVEF), diagnosed within 1 year of completing potentially cardiotoxic cancer therapy.\n* Current use of ≥1 HF medication started for CTRCD for at least 6 months with LVEF ≥55% by recently performed (≤6 months) echocardiogram, normal sex and age adjusted NT-proBNP or BNP ≤97.5th Centile, and no symptoms attributable to HF.\n* Reference ranges for NT-proBNP and BNP by age and sex:\n\n\\\u003C30 years: Female: NT-proBNP ≤196 pg\u002Fml, BNP ≤55 pg\u002Fml Male: NT-proBNP ≤104 pg\u002Fml, BNP ≤29 pg\u002Fml\n\n30-39 years: Female: NT-proBNP ≤209 pg\u002Fml, BNP ≤59 pg\u002Fml Male: NT-proBNP ≤102 pg\u002Fml, BNP ≤29 pg\u002Fml\n\n40-49 years: Female: NT-proBNP ≤233 pg\u002Fml, BNP ≤65 pg\u002Fml Male: NT-proBNP ≤137 pg\u002Fml, BNP ≤38 pg\u002Fml\n\n50-59 years: Female: NT-proBNP ≤299 pg\u002Fml, BNP ≤84 pg\u002Fml Male: NT-proBNP ≤195 pg\u002Fml, BNP ≤55 pg\u002Fml\n\n60-69 years: Female: NT-proBNP ≤399 pg\u002Fml, BNP ≤112 pg\u002Fml Male: NT-proBNP ≤333 pg\u002Fml, BNP ≤93 pg\u002Fml\n\n70-79 years: Female: NT-proBNP ≤743 pg\u002Fml, BNP ≤208 pg\u002Fml Male: NT-proBNP ≤763 pg\u002Fml, BNP ≤214 pg\u002Fml\n\n≥80 years: Female: NT-proBNP ≤2,704 pg\u002Fml, BNP ≤757 pg\u002Fml Male: NT-proBNP ≤6,792 pg\u002Fml, BNP ≤1,902 pg\u002Fml\n\n* Confirmation of LVEF ≥55% and normal volumes at baseline CMR (i.e., some patients recruited based on echocardiography, may be excluded if baseline CMR LVEF\u002Fvolumes are not normal). This is included given that the primary outcome includes the use of CMR LVEF.\n\nExclusion Criteria:\n\n* Indication for continuation of HF medications i.e., ongoing HF symptoms, chronic kidney disease (CKD), vascular disease, atrial or ventricular arrythmias, other (note: participants with hypertension will be switched to other guideline-based antihypertensive therapy).\n* Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).\n* Patients with cardiac devices i.e. defibrillator, CRT, pacemaker, etc.\n* Continued use of loop diuretic therapy for heart failure purposes i.e., furosemide.\n* Life expectancy \\\u003C1 year or metastatic disease.\n* Prior history of major cardiovascular event (defined as myocardial infarction, cerebral vascular event, admission for HF) or therapeutic cardiovascular procedure (e.g., percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)).\n* Issues that prevent communication, understanding or presentation for study-related visits and inability to provide informed consent.",{"count":275,"type":20},335,[277],"PHASE4","Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised. It is a side effect of cancer therapy which can occur as commonly as in 1 in 5 patients. When this occurs, heart failure medications are started to protect the heart from progressing to heart failure. With early detection and treatment, heart function recovers to normal in \\>80% of patients. Unfortunately, heart failure medications are associated with an undesirable long-term pill burden, financial costs, and side-effects (e.g., dizziness and fatigue). As a result, cancer survivors frequently ask if they can safely stop their heart failure medications once their heart function has returned to normal. Currently there is no scientific evidence in this area of Cardio-Oncology.\n\nTo address this knowledge gap, the investigators have designed a randomized control trial to assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. The investigators will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. The investigators will randomize patients with no other reasons to continue heart failure medications (e.g., kidney disease) to continuing or stopping their heart medications safely. All patients will undergo a cardiac MRI at baseline, 1 and 5 years with safety assessments at 6-8 weeks, 6 months and 3 and 5 years. The investigators will determine if stopping medications is non-inferior to continuing medications by counting the numbers of patients who develop heart dysfunction by 1 year in each group.",[91,24,280,281,282],"Cardiac Toxicity","Antineoplastics Toxicity","Cancer",[284],"cancer therapy related cardiac dysfunction","2026-03-25",{"date":287,"type":33},"2026-03-30",{"date":289,"type":33},"2024-03-04",{"date":291,"type":20},"2031-12",{"name":293,"class":40},"Dinesh Thavendiranathan",14,{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":305,"studyType":21,"phases":4,"briefSummary":306,"conditions":307,"keywords":310,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":72},"100607682","ml-score-prediction-of-cardiotoxicity-in-cancer-patients-receiving-anthracycline-chemotherapy-or-her2-targeted-therapies-100607682","NCT07191730","ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies","Machine Learning Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER-2-Targeted Therapies","ML-CardioTox","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Planned follow-up in cardio-oncology clinic as part of a baseline pre-treatment evaluation before a sequence of anthracycline and\u002For HER2-targeted therapy, according to the 2022 ESC recommendations\n* Inclusion regardless of prior exposure to potentially cardiotoxic anticancer therapies or thoracic radiotherapy\n\nExclusion Criteria:\n\n* Patients not covered by the French national health insurance system (Sécurité Sociale)\n* Patients for whom 12-month follow-up is planned outside the center performing the baseline pre-treatment evaluation",{"count":304,"type":20},600,"12 Months","Cancer treatments have improved substantially over the past decades, but some effective therapies such as anthracyclines and HER2-targeted agents are associated with severe cardiovascular adverse effects, including heart failure. Existing cardiovascular risk prediction scores have limited evidence in this setting.\n\nThe ML-CardioTox study is a prospective, multicenter, observational cohort conducted in 15 centers in France. The primary objective is to develop a one-year prediction score for cancer therapy-related cardiotoxicity using machine learning methods. A dedicated software platform will be used to standardize data collection and support integration of artificial intelligence tools.\n\nA total of 600 patients treated with anthracyclines or HER2-targeted therapies in cardio-oncology clinics will be enrolled over a one-year inclusion period starting in December 2024, with a 12-month follow-up. The primary endpoint is the occurrence of cardiotoxicity as defined by the 2022 European Society of Cardiology guidelines (hospitalization for heart failure, initiation or escalation of diuretic therapy, decline in cardiac function on imaging, or increase in cardiac biomarkers such as troponin or natriuretic peptides).\n\nSecondary objectives include comparison of the predictive performance of the machine learning-derived score with the established HFA-ICOS risk score. Patients will be managed according to routine clinical practice.\n\nThis study aims to improve prognostic stratification tools for patients receiving anthracyclines or HER2-targeted therapies, with the goal of better identifying those at high risk of developing cardiotoxicity during follow-up.",[24,91,308,309],"Neoplasms","Breast Neoplasms",[166,169,311,312,313],"HER2-targeted Therapy","Cardio-Oncology","Machine Learning","2026-03-17",{"date":316,"type":33},"2026-03-19",{"date":318,"type":33},"2025-10-29",{"date":320,"type":20},"2028-11",{"name":322,"class":40},"University Hospital, Caen",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":4},"100600163","artificial-intelligence-for-reconstruction-of-echocardiography-studies-100600163","NCT07093918","Artificial Intelligence for Reconstruction of Echocardiography Studies","Echocardiographic Detection of Cardiotoxicity Using the Ventripoint (VMS) 3D AI Echocardiography System Versus Conventional Echo Analyses and Cardiac MRI in Patients Receiving Chemotherapy","AIRES","Inclusion Criteria:\n\n* Aged 18 years or older\n* Received potentially cardiotoxic chemotherapy\n* Participant requires echocardiography surveillance as standard current practice\n\nExclusion Criteria:\n\n* Below the age of 18 years old\n* Inability to give informed consent\n* Implanted cardiac devices\n* Not having received cardiotoxic chemotherapy. Ineligible patients and patients not wishing to take part will be excluded, the reasons for this will be recorded and baseline CONSORT demographics noted including age, gender, ethnicity.",{"count":332,"type":20},120,"To investigate the clinical utility of both 3D and 2D artificial intelligence reconstruction echocardiography (V-echo and L-echo) assessment against conventional echocardiography and clinical cardiovascular magnetic resonance (CMR) imaging for the characterisation of cardiac function and detection of cardiotoxicity in patients receiving chemotherapy.\n\nDiagnostic accuracy of V-echo and L-echo for quantification of cardiac chamber sizes and systolic function (left ventricular ejection fraction (LVEF) and strain analyses) versus conventional echocardiography (C-echo) and CMR; workflow measures including imaging temporal measures of image acquisition, registration and analysis versus conventional approaches; survey of markers of acceptability by patients and sonographers; cost effectiveness analysis of V-echo and L-echo versus conventional echocardiography; assessment of the relationship between 3D strain parameters derived from V-echo data, 2D strain parameters derived from L-echo and correlation with conventional markers of cardiac function, namely LVEF and global longitudinal strain.",[24],[336,337,338,339,227],"Echocardiography","Artificial intelligence","Reconstruction","Cardiovascular magnetic resonance (CMR)","2026-02-10",{"date":342,"type":33},"2026-02-11",{"date":344,"type":20},"2026-04",{"date":346,"type":20},"2030-11",{"name":348,"class":349},"The Royal Wolverhampton Hospitals NHS Trust","OTHER_GOV",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":16,"minAge":357,"maxAge":17,"enrollmentInfo":358,"targetDuration":4,"studyType":51,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":373},"100622324","early-identification-of-cardivascular-damage-induced-by-chemotherapy-and-antineoplastic-treatments-in-pediatric-age-100622324","NCT07382141","Early Identification of Cardivascular Damage Induced by Chemotherapy and Antineoplastic Treatments in Pediatric Age","PREDICT","Inclusion Criteria:\n\n* Diagnosis of oncological pathology and need for antineoplastic treatment\n\nExclusion Criteria:\n\n* None","0 Years",{"count":359,"type":20},400,[252],"To test whether the implementation of new diagnostic techniques (ultrasonography, speckle tracking, vascular stiffness study, cardiac MRI, and histologic studies) allows in CAYA (Childern, Adolescents, and Young Adults) cancer survivors a more sensitive and earlier identification of cardiovascular damage resulting from antineoplastic therapy that develops either acutely or remotely after completion of antineoplastic therapy.",[24],[197],"2026-01-26",{"date":366,"type":33},"2026-02-02",{"date":368,"type":33},"2025-03-17",{"date":370,"type":20},"2028-12-31",{"name":372,"class":40},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",5,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":133,"minAge":381,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":51,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":72},"100561821","breast-cancer-fitness-and-exercise-for-heart-health-the-be-fitter-study-100561821","NCT06595147","Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study","BE-FITTER","Inclusion Criteria:\n\n* Age ≥60 years\n* Previously diagnosed with early-stage (I-III) BC\n* Completed (≥1 year post) primary cardiotoxic treatment (anthracycline-based chemotherapy or trastuzumab-based biological therapy).\n\nExclusion Criteria:\n\n* Have a history of coronary artery disease, heart failure, persistent and permanent arrhythmia (e.g. currently in atrial fibrillation), stroke, or chronic obstructive pulmonary disease\n* Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping ST segment depression on electrocardiogram) during the cardiopulmonary (VO2peak) test\n* Have any research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing\n* Currently performing structured exercise training (defined as ≥30 mins\u002Fday of moderate-to-vigorous aerobic and\u002For resistance exercise training on ≥4 days\u002Fweek)\n* Are unwilling to be randomized to either ExT or STRETCH","60 Years",{"count":50,"type":20},[252],"The chemotherapy medications used for breast cancer treatment are important for achieving a cure, but a potential side effect is that they can cause a decline in functional capacity (reduced exercise tolerance and impaired physical function) and increase the risk of cardiovascular disease. The risks of decreased functional capacity and cardiovascular disease are highest in breast cancer survivors as they grow older. The factors causing the decline in functional capacity are not well understood, however they may be related to a reduction in cardiac function (e.g. decreased pumping ability of the heart) or skeletal muscle function (reduced muscle blood flow and oxygenation). Exercise training is used for other populations at risk for cardiovascular disease (such as cardiac rehabilitation), but is not routinely offered to breast cancer survivors. Therefore this research study wants to test whether exercise training can improve heart and muscle health, and increase functional capacity in up to 60 older breast cancer survivors aged \\>60 years old who previously received chemotherapy drugs that can affect the heart.\n\nThe purpose of this study is to compare two rehabilitation approaches: a 12-week structured exercise training program or a 12-week stretching-yoga program. The investigators want to compare whether these programs can improve functional capacity, and heart and skeletal muscle function. To do this, some of the participants in this study will be randomly enrolled in the structured exercise training program and others will be randomly enrolled in the stretching-yoga program.",[139,386,91,24],"Disability Physical",[388,389,390,391,282,392],"Exercise Training","Fitness","Heart","Muscle","Survivorship","2026-01-05",{"date":395,"type":33},"2026-01-08",{"date":397,"type":33},"2024-07-01",{"date":399,"type":20},"2026-12-20",{"name":401,"class":40},"University of Alberta",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":410,"enrollmentInfo":411,"targetDuration":4,"studyType":51,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":72},"100441088","the-himalayas-trial-and-lifestyle-changes-in-pediatric-adolescent-and-young-adult-cancer-survivors-study-a-multicentre-randomized-controlled-trial-100441088","NCT05023785","The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial","The Harmonized Interventions to Maintain Health Via Appropriate Risk Factor Modification and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial","HIMALAYAS","Inclusion Criteria:\n\n1. Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;\n2. Be 18-45 years of age at the time of enrolment;\n3. Received cancer treatment(s) with known cardiovascular risks (e.g., anthracyclines, trastuzumab, radiotherapy, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors);\n4. Be cancer-free at the time of enrollment;\n5. Stage B Heart Failure (SBHF)\n\n   * In patients with availability of pre-treatment imaging:\n\n     * ≥10% decrease in LVEF at post-treatment compared to pre-treatment\n     * ≥15% decrease in GLS at post-treatment compared to pre-treatment\n   * No pre-treatment imaging:\n\n     * LVEF ≤53% in women\u002F51% in men\n     * GLS \\>-18%\n     * Left ventricular hypertrophy (LV mass\u002Fbody surface area: \\>95 g\u002Fm2 for women or \\>115 g\u002Fm2 for men)\n     * Concentric remodelling (\\>0.42 relative wall thickness)\n     * Diastolic dysfunction (≥ grade 1)\n     * BNP ≥35pg\u002Fml or NT-proBNP ≥125pg\u002Fml\n\nExclusion Criteria:\n\n1. Have an absolute or unresolved relative contraindication to exercise according to the American College of Sports Medicine guidelines;\n2. Have an untreated physical or mental health concern that precludes safe and effective exercise participation;\n3. Have established CVD (excluding mildly reduced LVEF as described above);\n4. Be pregnant at time of recruitment;\n5. Be currently engaging in frequent high-intensity exercise (\\>1 high-intensity exercise session per week);\n6. Have substantial barriers to participating, including (1) living too far from study centre or (2) being unable or willing to comply with the study protocol.","45 Years",{"count":412,"type":20},336,[252],"Pediatric, adolescent and young adult cancer survivors (PAYA-CS) are at higher risk of cardiovascular (CV) morbidity and mortality. This is a consequence of prior cancer-related therapies that have the potential of producing cardiac dysfunction, reducing cardiorespiratory fitness (reduced VO2peak) and psychosocial morbidities (i.e., anxiety and depression). A reduction of physical activity levels can evoke functional limitations resulting in a vicious cycle of reduced exercise tolerance and physical deterioration. To date, there is limited evidence on the use of non-pharmacological strategies such as Cardio-Oncology Rehabilitation (CORE) including structured exercise, behavioural support and risk factor management to improve the outcomes of this underserved population. The HIMALAYAS study is a randomized controlled trial designed to evaluate the impact of a CORE intervention (consisting of six-months home and onsite-based structured moderate to high-intensity aerobic exercise training and CVD risk factor management) on CV and psychosocial health, and the cardiovascular disease risk in PAYA-CS with mild heart dysfunction (stage B heart failure) compared to standard of care (i.e. providing guidance on the current exercise recommendations for cancer survivors). The primary objective of the HIMALAYAS study is to determine whether a six-month supervised CORE intervention, consisting of individualized moderate to high-intensity aerobic exercise training, CVD risk factor modification and enhanced online behavioral support, improves cardiorespiratory fitness (VO2peak; primary outcome), cardiac function, CVD risk factors and biomarkers, and patient-reported outcomes (PROs) at six- months follow-up compared to standard of care (CON) in PAYA-CS with stage B heart failure. The secondary objective is to assess the same outcomes at 12- and 24-months follow-up. We will recruit 336 patients across 5 sites in Canada and upto 134 patients at UHN in 3 years and conclude in 6 years.",[91,24,282],[417,418,419,420,421],"Adolescents and Young Adults","Exercise Therapy","Behavioral and Peer Support","Cardiac Rehabilitation","Cancer Survivor","2025-11-25",{"date":424,"type":33},"2025-11-26",{"date":426,"type":33},"2024-01-01",{"date":428,"type":20},"2027-03",{"name":430,"class":40},"University Health Network, Toronto",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":438,"conditions":439,"keywords":446,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":72},"100468249","patient-similarity-for-decision-making-in-prevention-of-cardiovascular-toxicity-pact-a-feasibility-study-100468249","NCT05377320","PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study","Inclusion Criteria:\n\n1. Patients ≥18 years with a history of cancer.\n2. Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.\n3. Clinically at intermediate, high, or very high risk for cardiovascular diseases determined based on imprecise clinical risk models, such as those used for cardiac dysfunction.\n4. Ability to understand a written informed consent form, and willing to sign it prior to study registration.\n\nExclusion Criteria:\n\n1. Patient \\\u003C18 years.\n2. Without a personal history of cancer.\n3. Existing cardiomyopathy diagnosed after cancer diagnosis.\n4. Documented cognitive impairment.\n5. Patient or patient representative who is unable and unwilling to sign the informed consent form.",{"count":50,"type":20},"This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.",[91,440,441,442,443,444,445,24],"Coronary Artery Disease","Peripheral Artery Disease","Ischemia","Hypertension","Diabetes Mellitus","Cardiomyopathies",[447,448,449,450,451,452,453],"clinical decision aid","cancer","cardiac dysfunction","cardio-oncology","artificial intelligence","machine learning","adverse events","2025-10-09",{"date":456,"type":33},"2025-10-14",{"date":458,"type":20},"2026-12",{"date":460,"type":20},"2028-12",{"name":462,"class":40},"Medical College of Wisconsin",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":51,"phases":472,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":490},"100317923","phase-3-s1501-dual-observational-and-randomized-cohort-study-of-patients-with-metastatic-her-2-breast-cancer-at-risk-of-cardiac-toxicity-100317923","NCT03418961","S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity","Prospective Observational Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity","Inclusion Criteria:\n\n* STEP 1 REGISTRATION\n\nPatients must:\n\n1. Have metastatic breast cancer, AND\n2. Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND\n3. Be receiving the trastuzumab-based HER-2 targeted therapy for metastatic disease in first, second, third-, or fourth-line setting. Patients may have brain metastasis. There is no limit for number of doses of HER-2 targeted therapy prior to registration.\n\nExamples of eligible HER-2 targeted therapy:\n\n* Trastuzumab or a trastuzumab biosimilar\n* Trastuzumab + chemotherapy or hormonal therapy\n* Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab, lapatinib, and tucatinib)\n* Ado-trastuzumab (Kadcyla®)\n* Fam-trastuzumab deruxtecan (Enhertu) NOTE: Patients on lapatinib without trastuzumab are not eligible. Planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted.\n\n  * Patients must be at increased risk for cardiotoxicity defined by at least one of the following:\n\n    1. Previous anthracycline exposure OR\n    2. 1 or more of the following risk factors for heart disease:\n\n       * LVEF 50-54% by local ECHO read\\*\n       * Age ≥ 65\n       * BMI ≥ 30 kg\u002Fm2\n       * Current or prior anti-hypertensive therapy\n       * Diagnosis of coronary artery disease (CAD)\n       * Diagnosis of diabetes mellitus\n       * Diagnosis of atrial fibrillation\u002Fflutter Note: ECHO can be performed at any time prior to registration with the most recent being sent.\n  * Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration or planning to take once registered to Step 1 a beta blocker, ARB, or ACE inhibitor, in order to be randomized (Arms 1 and 2).\n\nPatients enrolling in the observational cohort (Arm 3) must be currently taking a beta blocker, ARB, or ACE inhibitor at the time of Step 1 Registration.\n\n* Patients must have a Zubrod Performance status of 0-2\n* Patients must have a complete physical examination and medical history within 28 days prior to registration\n* Patients must have LVEF \\>= 50% echocardiogram (2D or 3D) within 28 days prior to registration. The echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab.\n\nIf a 3D echocardiogram is performed at baseline, sites must ensure that standard 2D images, including 40chamber and 2-chamber views, are also obtained and submitted at subsequent timepoints.\n\nAll follow-up echocardiograms (every 12 weeks) must be performed using 2D imaging to allow for standardized assessments. Follow-up scans must be completed at a site that can provide 2D images per protocol requirements. The echocardiograms cannot be submitted for central read until after Step 1 registration is complete.\n\n* Patients must have adequate hepatic function as evidenced by all of the following within 28 days prior to registration:\n\n  * Serum bilirubin \\\u003C 3.0 x institutional upper limit of normal (IULN)\n  * Serum glutamic oxaloacetic transaminase (SGOT)\u002Faspartate aminotransferase (AST) and serum glutamic pyruvic transaminase (SGPT)\u002Falanine aminotransferase (ALT) \\\u003C 5.0 x IULN\n* Patients must not be dialysis dependent\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer on active surveillance, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years\n* Patients must not be pregnant or nursing due to potential fetal or nursing infant harm; women\u002Fmen of reproductive potential must have agreed to use an effective contraceptive method, a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures\n* Patients must be willing to submit blood specimens\n* Sites must seek additional patient consent for the future use of specimens\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB regulations.\n* As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2 REGISTRATION (Randomization)\n* Patients must not be registered to step 2 until confirming via RAVE EDC that the patient's LVEF by echocardiogram was \\>= 50% by central review. Patients must be registered within 21 calendar days of submission of the ECHO study\u002F\n* Site must verify that there is no known change in the step 1 eligibility since initial registration",{"count":471,"type":20},491,[473],"PHASE3","This trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.",[24,476,477,478,479],"HER2\u002FNeu Positive","Metastatic Malignant Neoplasm in the Brain","Recurrent Breast Carcinoma","Stage IV Breast Cancer AJCC v6 and v7","2025-10-03",{"date":482,"type":33},"2025-10-08",{"date":484,"type":33},"2017-11-01",{"date":486,"type":20},"2027-09-15",{"name":488,"class":489},"SWOG Cancer Research Network","NETWORK",590,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":16,"minAge":498,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":500,"conditions":501,"keywords":509,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":4},"100605065","cardiovascular-complications-in-patients-undergoing-allogeneic-hematopoietic-stem-cell-transplantation-100605065","NCT07157670","Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.","ALLOCARDIOTOX","Inclusion Criteria:\n\n* Age ≥ 15 years\n* Informed about the study and without objection to participation (or with consent from legal guardians)\n* Undergoing allogeneic HSCT\n\nExclusion Criteria:\n\n* Patient not followed up at the participating center\n* Pregnant or breastfeeding women\n* Patient not affiliated with social security\n* Patient under guardianship, curatorship, or legal protection","15 Years",{"count":359,"type":20},"Allogeneic hematopoietic stem cell transplantation (HSCT) represents a major therapeutic strategy for malignant hematologic diseases, with the number of procedures steadily increasing in France each year. Conditioning and maintenance regimens carry a risk of both short- and long-term cardiotoxicity, leading to serious cardiovascular events including acute coronary syndrome (ACS), cardiac dysfunction, arrhythmias, pulmonary hypertension, and pericardial effusion. The pathophysiology of cardiotoxicity in HSCT patients remains poorly understood.\n\nIt is therefore crucial to investigate underlying mechanisms and identify predictive factors of cardiotoxicity in order to provide appropriate cardiological follow-up and management. Current European Society of Cardiology guidelines recommend routine monitoring of HSCT patients with echocardiography and cardiac biomarkers (NT-proBNP, troponin), although these recommendations are based on small-scale studies. The cardiodepressor factor DPP3 has shown promising results in cardio-oncology, with a causal role in anthracycline-induced cardiac dysfunction. Its role in HSCT-related cardiotoxicity requires further evaluation.\n\nThis multicenter study of HSCT recipients will be a valuable resource, enabling a better understanding of the pathophysiology of cardiotoxicity and prognosis. It will highlight imaging (echocardiography, calcium score, supra-aortic Doppler), electrocardiographic, and biological markers (including DPP3) associated with prognosis.",[24,502,503,504,505,506,507,508,313],"DPP3","HSCT","Allogeneic Hematopoietic Stem Cell Transplantation","ACS - Acute Coronary Syndrome","Cardiac Dysfunction","Arrythmia, Cardiac","Pulmonary Hypertension",[502,503,24,510,313],"Allogeneic hematopoietic stem cell transplantation","2025-09-02",{"date":513,"type":33},"2025-09-05",{"date":515,"type":20},"2025-09-15",{"date":517,"type":20},"2028-09-15",{"name":519,"class":40},"Assistance Publique - Hôpitaux de Paris",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":16,"minAge":526,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":72},"100585040","optimizing-radiation-dose-and-utilizing-wearable-devices-to-reduce-arrhythmia-risk-in-patients-undergoing-thoracic-radiotherapy-a-prospective-cohort-study-100585040","NCT06897189","Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study","Inclusion Criteria:\n\n* Patients with solid tumors requiring thoracic radiotherapy\n* Undergoing curative-intent radiotherapy\n* Expected survival \\> 4 months\n* Adults aged ≥ 20 years\n* ECOG performance status 0-2\n* Classified as moderate-to-high risk for radiation-induced cardiotoxicity per the 2022 ESC guidelines\n* Able to read, understand, and sign the informed consent form\n\nExclusion Criteria:\n\n* History of prior thoracic radiotherapy\n* Inability to provide informed consent or refusal to participate\n* Pre-existing arrhythmia diagnosed through medical history or pre-treatment evaluation\n* Expected survival ≤ 4 months\n* Classified as low risk for radiation-induced cardiotoxicity per the 2022 ESC guidelines\n* Unsuitability for Wearable CR device use","20 Years",{"count":528,"type":20},111,"This prospective observational cohort study aims to assess the risk of radiation-induced cardiotoxicity in patients undergoing thoracic radiotherapy by integrating real-time arrhythmia monitoring using wearable cardiac rehabilitation (wearable CR) devices and AI-based cardiac substructure segmentation. The study will analyze radiation dose exposure to key cardiac structures, including the sinoatrial node (SAN) and pulmonary veins (PV), to identify risk factors for atrial fibrillation (AF) and other arrhythmias. Patients will receive wearable CR monitoring at 3, 12, and 24 months post-radiotherapy, with cardiology follow-up and intervention based on standard clinical guidelines. The study will recruit 111 patients over three years, with a two-year follow-up after radiotherapy. The primary endpoint is the incidence of grade 3+ AF within 2 years, with secondary outcomes including any-grade arrhythmia rates, arrhythmia burden, and survival analysis. By establishing a prospective thoracic radiotherapy patient cohort, this study aims to identify dose-related risk factors, improve early detection and management of radiation-induced arrhythmias, and provide evidence-based strategies to enhance treatment safety and efficacy.",[24,531,532,533,534],"Thoracic Radiotherapy","Wearable Electronic Devices","Thoracic Neoplasms","Atrial Fibrillation","2025-04-16",{"date":537,"type":33},"2025-04-18",{"date":539,"type":20},"2025-05",{"date":541,"type":20},"2030-02-16",{"name":543,"class":40},"Yonsei University",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":133,"minAge":17,"maxAge":552,"enrollmentInfo":553,"targetDuration":4,"studyType":51,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":568},"100470497","imaging-versus-cardiac-biomarker-monitored-her2-directed-therapy-in-patients-with-breast-cancer-100470497","NCT05406635","Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer","A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer","HER2BIC","Inclusion Criteria:\n\n* Patients with non-metastatic HER2 positive breast cancer\n* Scheduled for standard chemotherapy and HER2 directed therapy with trastuzumab +\u002F- pertuzumab\n* Age \\> 18 years\n* Sinus rhythm on ECG\n* NT-proBNP below125 pg\u002Fml\n* Troponin below threshold limit value\n* LVEF \\> 55% by MUGA scan or an echocardiogram\n\nExclusion Criteria:\n\n* Contra indications for cardiac magnetic resonance imaging (CMRI)\n* Chronic obstructive pulmonary disease with FEV1 \\\u003C80 % of predicted","90 Years",{"count":554,"type":20},220,[252],"Due to a risk of heart failure during HER2 directed therapy in breast cancer, treatment is monitored with imaging of myocardial function, which is resource demanding for both patients and the health care system. The purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.",[24,558],"HER2-positive Breast Cancer","2025-04-04",{"date":561,"type":33},"2025-04-08",{"date":563,"type":33},"2021-10-01",{"date":565,"type":20},"2027-09-01",{"name":567,"class":40},"Odense University Hospital",4,{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":16,"minAge":577,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":51,"phases":580,"briefSummary":581,"conditions":582,"keywords":586,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":294},"100340330","cardiovascular-prevention-strategies-in-elderly-patients-with-cancer-cartier-clinical-trial-100340330","NCT03711110","Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)","Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies","CARTIER","Inclusion Criteria:\n\n* \\> 65 years old\n* Expected survival \\>1 year\n* Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma\n* Signature on the informed consent\n\nExclusion Criteria:\n\n* Patients included in clinical trials will be excluded if they interfere with the CARTIER follow-up protocol. If they do not interfere they can be included\n* Patients who had received previous potentially cardiotoxic anticancer treatment","65 Years",{"count":579,"type":20},514,[252],"The CARTIER study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria).\n\nThe primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality.\n\nOther secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and\u002For urgent care due to cardiovascular complications, hospitalization and\u002For urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis.\n\nA total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited.\n\nThe incidence of primary and secondary outcomes will be measured at 2 and 5 years",[583,584,585,24],"Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)","Elderly","Antineoplastic Agents",[24,584,587,588,589,173,590,591,592,593,594,595],"Antineoplastic agents","Cardiovascular monitoring","Cardioprotection","Chemically-Induced Disorders","Radiation Injuries","Drug-Related Side Effects and Adverse Reactions.","Primary prevention","Secondary prevention.","Mortality","2025-03-18",{"date":598,"type":33},"2025-03-21",{"date":600,"type":33},"2019-08-02",{"date":602,"type":20},"2025-11-30",{"name":604,"class":40},"Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":133,"minAge":17,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":51,"phases":613,"briefSummary":614,"conditions":615,"keywords":624,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":568},"100474986","phase-4-sacubitrilvalsartan-in-primary-prevention-of-the-cardiotoxicity-of-systematic-breast-cancer-treatment-mainstream-100474986","NCT05465031","Sacubitril\u002FValsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)","Sacubitril\u002FValsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent","Inclusion Criteria:\n\n* Written informed consent\n* Female gender, aged 18 years and over\n* Patients with histologically confirmed breast cancer and complete assessment of tumor phenotype (Estrogen receptor - ER, Progesterone receptor - PR, Human epidermal growth factor receptor 2 - HER2, Kiel - Ki67)\n* Ability to take oral medication and willingness to adhere to the planned regimen\n* Tumor grade IA-IIIC or oligometastatic grade IV\n* Radical treatment plan including surgery\n* Plan of use of systemic treatment (preoperative, postoperative or combined) with anthracyclines and\u002For anti-HER2 drugs\n* Eastern Cooperative Oncology Group (ECOG) 0-2 general status\n* LVEF ≥ 50% as assessed by echocardiography\n* Sinus rhythm\n\nExclusion Criteria:\n\n* Prior anthracycline-based chemotherapy and\u002For thoracic radiotherapy (prior to diagnosis of the cancer being the present cause of therapy)\n* Clinically relevant HF (NYHA II-IV)\n* Myocardial infarction (MI) within the last \\\u003C 3 months\n* Symptomatic hypotension or systolic blood pressure (SBP) \\\u003C 90 mmHg\n* Significant valvular disease, symptomatic coronary artery disease (CCS\\>2), significant atrioventricular (AV) block, symptomatic sinus node dysfunction\n* Expected survival \\\u003C12 months\n* Glomerular filtration rate (GFR) \\\u003C30 ml\u002Fmin\u002F1.73 m2 (screening visit)\n* K+\\>5.5mmol\u002FL (screening visit)\n* Contraindications to angiotensin converting enzyme inhibitor (ACE-I)\u002Fangiotensin II receptor blocker (ARB) or LCZ696 if not listed among criteria\n* Active untreated liver disease\n* Pregnancy\n* Conditions\u002Fcircumstances that may lead to non-compliance with medical staff recommendations (e.g. active drug\u002Falcohol dependence, poorly controlled mental illness)",{"count":304,"type":20},[277],"Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020. Although the modern treatment strategies, based on the complex care, which consists of surgery, radiotherapy, hormone therapy, and targeted chemotherapy directed at specific cancer molecules have substantially reduced the risk of death due to breast cancer, their wide adoption results in the wider prevalence of cardiotoxicity, defined as either symptomatic heart failure, or asymptomatic contractile dysfunction. The occurrence of cardiotoxicity induced by anti-cancer therapies is estimated at 5-15%, and its development is the primary cause of therapy termination, which significantly reduces the probability of the efficacy of treatment. Several attempts have been made to determine the efficacious preventive strategy, which could diminish the risk of cancer-therapy induced cardiotoxicity. The results of the prior studies indicated a trend towards lower risk of troponin elevation, or left ventricular contractile dysfunction with the introduction of drugs interfering with the renin-angiotensin-aldosterone (RAA) axis, which constitute the primary treatment modality in heart failure with reduced ejection fraction (HFrEF). Sacubitril\u002Fvalsartan, the novel therapeutic agent, has been demonstrated to significantly improve prognosis in patients with HFrEF. Prior retrospective, small, single-center studies have shown that treatment with sacubitril\u002Fvalsartan may reduce the risk of cancer-therapy induced cardiotoxicity, or reverse contractile dysfunction caused by anti-cancer therapy. However, no large randomized data confirmed these findings.\n\nTherefore, the Sacubitril\u002FValsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent) study, has been designed to verify, whether the preventive use of sacubitril\u002Fvalsartan administered in the doses recommended in patients with HFrEF in breast cancer patients undergoing adjuvant chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will reduce the incidence of cardiotoxicity defined as impaired left ventricular systolic function on transthoracic echocardiography (TTE). In the trial, a total of 480 patients with histologically confirmed breast cancer, who are eligible for chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will undergo 1:1 randomization to either preventive treatment with sacubitril\u002Fvalsartan or placebo. The patients will be followed for 24 months, and will have repetitive efficacy and safety examinations, including echocardiography, MRI (optionally), electrocardiography including 24-h Holter monitoring, blood tests, functional capacity tests and quality of life assessment.",[139,616,617,618,619,620,621,622,91,280,623,166,24],"Neoplasm, Breast","Breast Diseases","Antihypertensive Agents","Sacubitril\u002FValsartan","Angiotensin II Type 1 Receptor Blockers","Angiotensin Receptor Antagonists","Molecular Mechanisms of Pharmacological Action","Cancer, Therapy-Related",[625,619,626,336,173,139,24,169,627,628,589],"LCZ696","Magnetic Resonance Imaging","Trastuzumab","Heart failure","2025-03-11",{"date":631,"type":33},"2025-03-14",{"date":633,"type":33},"2024-04-17",{"date":635,"type":20},"2029-02",{"name":637,"class":40},"Silesian Centre for Heart Diseases",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":16,"minAge":645,"maxAge":17,"enrollmentInfo":646,"targetDuration":4,"studyType":51,"phases":648,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":660},"100581718","phase-3-cardioprotection-on-chemotherapy-induced-cardiotoxicity-100581718","NCT06853951","Cardioprotection on Chemotherapy-Induced Cardiotoxicity","The Effect of Cardioprotective Medications on Chemotherapy-Induced Cardiotoxicity in Childhood Acute Leukemia","Inclusion Criteria:\n\n* Willingness of the legal representative of research participant to participate in the study by giving \"informed consent.\"\n* Ability to take oral medication.\n* Age 2-18 years at the time of diagnosis.\n\nExclusion Criteria:\n\n* Documented allergy to cardioprotective medications","1 Year",{"count":647,"type":20},30,[473],"The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.",[24],"2025-02-25",{"date":653,"type":33},"2025-03-03",{"date":655,"type":33},"2023-07-18",{"date":657,"type":20},"2025-07-18",{"name":659,"class":40},"Ain Shams University",2,{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":16,"minAge":669,"maxAge":670,"enrollmentInfo":671,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":673,"conditions":674,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":72},"100382684","cardiotoxicity-assessment-through-comprehensive-heart-imaging-to-predict-heart-failure-100382684","NCT04262830","Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure","CATCH-HF: Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure","CATCH-HF","Inclusion Criteria:\n\n* English and Spanish speaking male and female subjects, ages 13-39 years old\n* Diagnosis of cancer at age \\\u003C22 years\n* Previously treated with anthracyline therapy for cancer, with diagnosis at least two years prior.\n\nExclusion Criteria:\n\n* Patients who have a contraindication to cardiac MRI, including the presence of non-MRI compatible metallic implants.\n* Medical, psychiatric, and\u002For social disorder that would prevent successful completion of planned study testing or would preclude the subject from undergoing the cardiac MRI without anesthesia.\n* Patients with a history of congenital heart disease (more significant than a history of patent foramen ovale or patent ductus arteriosus).\n* Pregnancy (at the time of enrollment).","13 Years","39 Years",{"count":672,"type":20},150,"Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.",[24,675,91],"Pediatric Cancer","2025-01-24",{"date":678,"type":33},"2025-01-28",{"date":680,"type":33},"2019-09-30",{"date":682,"type":20},"2030-09-30",{"name":684,"class":40},"Hari Narayan",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":577,"enrollmentInfo":692,"targetDuration":4,"studyType":51,"phases":693,"briefSummary":694,"conditions":695,"keywords":698,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":72},"100493282","clinical-and-diagnostic-significance-of-endothelial-dysfunction-and-myocardial-contractility-in-patients-with-aml-100493282","NCT05703126","Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML","Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* patients with acute myeloid leukemia receiving anthracycline-containing polychemotherapy regimens aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before starting chemotherapy;\n* availability of informed consent of the patient to participate in the study.\n\nExclusion Criteria:\n\n* acute violation of cerebral circulation in history;\n* a history of myocardial infarction;\n* the presence of diabetes mellitus type I and II;\n* the presence of chronic kidney disease C1-C5 stages;\n* the presence of stable angina III-IV functional classes;\n* the presence of unstable angina pectoris;\n* the presence of atrial fibrillation and flutter;\n* the presence of arterial hypertension of 2-3 degrees;\n* the presence of other oncological diseases;\n* inflammatory diseases in the acute stage;\n* diseases of the thyroid gland;\n* therapy with any monoclonal antibodies in history;\n* a positive test for the presence of HIV and hepatitis B and C;\n* alcoholism, drug addiction;\n* the presence of neuroleukemia, extramedullary foci of leukemia;\n* refusal of the patient to be examined.\n* the emergence of life-threatening situations during the study;\n* development in patients of diseases related to the non-inclusion criteria;\n* refusal of the patient to further examination.",{"count":162,"type":20},[252],"Acute myeloid leukemia (AML) is a clonal neoplastic disease of the hematopoietic tissue associated with a mutation in the precursor cell of hematopoiesis, which results in a differentiation block and uncontrolled proliferation of immature myeloid cells.\n\nAnthracycline antibiotics have been an integral part of the treatment of acute myeloid leukemia since the 1970s. However, the clinical usefulness of anthracyclines is limited primarily by the high incidence of cardiotoxicity. According to the European Society of Cardiology guidelines for cardio-oncology, cardiovascular toxicity is defined as any impairment of cardiac function associated with anticancer treatment, as the term encompasses both a wide range of possible clinical manifestations and an etiological relationship with various treatments, including chemotherapy, radiation therapy, immunotherapy and treatment with targeted drugs. Cardiovascular toxicity can be acute, subacute or delayed, manifesting many years after chemotherapy or radiation therapy, involving a number of cardiac structures, which can lead to the development of heart failure, coronary heart disease, valvular heart disease, arrhythmias, including cardiac conduction disorders and diseases of the pericardium.\n\nAnthracycline-induced cardiotoxicity is the negative effect of anthracyclines on normal cardiac activity due to their toxic effects on the heart muscle and the cardiac conduction system. Anthracycline-induced cardiotoxicity manifests as asymptomatic left ventricular dysfunction in 57% of treated patients and restrictive or dilated cardiomyopathy leading to congestive heart failure (CHF) in 16% to 20% of patients. Anthracycline-induced congestive heart failure is often resistant to therapy and has a mortality rate of up to 79%. Thus, there is a need for early detection of cardiovascular dysfunction associated with chemotherapy treatment of acute myeloid leukemia in order to timely prescribe drug therapy.\n\nPurpose of the study To optimize the early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment of instrumental and laboratory research parameters.\n\nExpected results Based on a comprehensive analysis using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal strain of the myocardium, biochemical markers of endothelial damage and cardiac biomarkers, a correlation between violations of the contractility of the left ventricular myocardium and violations of the vasoregulatory function of the vascular endothelium will be revealed, which will allow developing an algorithm for early detection of cardiomyopathy and vascular complications in patients with acute myeloid leukemia during chemotherapy treatment.",[696,24,697],"Acute Myeloid Leukemia, Adult","Endothelial Dysfunction",[699,24,697,700,169],"Acute Myeloid Leukemia","Polychemotherapy","2024-11-02",{"date":703,"type":33},"2024-11-05",{"date":705,"type":33},"2022-12-01",{"date":707,"type":20},"2025-08-03",{"name":709,"class":40},"Samara State Medical University",{"id":711,"slug":712,"hasResults":12,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":716,"eligibilityCriteria":717,"healthyVolunteers":12,"sex":133,"minAge":17,"maxAge":718,"enrollmentInfo":719,"targetDuration":4,"studyType":51,"phases":720,"briefSummary":721,"conditions":722,"keywords":723,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":730,"lastUpdatePostDateStruct":731,"startDateStruct":733,"completionDateStruct":735,"leadSponsor":737,"locationsCount":72},"100563960","dietary-restriction-to-prevent-cardiotoxicity-in-breast-cancer-patients-100563960","NCT06622954","Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients","Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.","PROTECT-COR","Inclusion Criteria:\n\n* women with newly diagnosed triple negative breast cancer with an indication for (neo-)adjuvant ATC-based chemotherapy and of intent to start anticancer treatment;\n* age between 18 and 75 years;\n* written informed consent;\n* body mass index ≥ 19.\n\nExclusion Criteria:\n\n* Allergic to any of the ingredients of the diet;\n* Known history of cardiac dysfunction;\n* Severe morbidity with the inability to receive anticancer treatment.\n* Participation in another clinical trial with an intervention arm (database and\u002For biobank studies excluded);\n* Pregnant women\n* Previous treatment with anthracycline\n* Estrogen receptor positive status","75 Years",{"count":5,"type":20},[252],"The goal of this clinical trial is to compare a dietary intervention with a regular diet in patients with early breast cancer undergoing anthracycline based chemotherapy. The main question it aims to answer is:\n\nWhat are the effects of a short-term diet with 30% caloric and 70% protein restriction (PCR) on cardiotoxicity induced by anthracycline treatment in women with newly diagnosed invasive breast cancer.\n\nResearchers will compare the control group with dietary intervention group to see if cardiotoxicity -measured by concentrations of high-sensitivity troponin T (hsTnT) levels- will be different between these two groups.",[24,139],[724,725,169,726,727,728,729,24],"Dietary restriction","Diet","High sensitivity troponin T","HsTnT","Oxidative stress","Breast cancer","2024-09-30",{"date":732,"type":33},"2024-10-02",{"date":734,"type":33},"2023-05-10",{"date":736,"type":20},"2026-05",{"name":738,"class":40},"Erasmus Medical Center"]