[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-toxicity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-toxicity":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,72,113,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100530181","phase-4-the-stop-med-ctrcd-trial-100530181",false,"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.","ALL","18 Years",{"count":20,"type":21},335,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"Heart Failure","Cardiotoxicity","Cardiac Toxicity","Antineoplastics Toxicity","Cancer",[33],"cancer therapy related cardiac dysfunction","RECRUITING","2026-03-25",{"date":37,"type":38},"2026-03-30","ACTUAL",{"date":40,"type":38},"2024-03-04",{"date":42,"type":21},"2031-12",{"name":44,"class":45},"Dinesh Thavendiranathan","OTHER",14,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100482218","phase-2-statins-for-reduction-of-cardiac-toxicity-in-patients-receiving-her2-targeted-100482218","NCT05559164","Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted","STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed diagnosis of Stage I-III female breast cancer (including inflammatory breast cancer)\n* Scheduled to receive neoadjuvant\u002Fadjuvant HER2 targeted therapy\n* Between ≥18 years of age\n* Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Female patients must agree to use effective barrier contraception during the period of therapy\n* Baseline LVEF ≥ 50%\n* Prior cancers allowed if no evidence of disease in last 5 years\n* ECOG 0-2\n* No prior history of treatment with HER2 targeted therapy or anthracyclines based chemotherapy\n* Adequate bone marrow function:\n\nI. ANC ≥ 1000\u002FuL II. platelet count ≥ 100,000\u002FuL III. hemoglobin ≥ 9.0 g\u002FdL\n\n• Adequate hepatic function: I. Total bilirubin ≤ 1.5 X ULN II. AST (SGOT) ≤ 5 X ULN III. ALT (SGPT) ≤ 5 X ULN\n\n* Adequate renal function, Creatinine \\\u003C 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL\u002Fmin as estimated using the Cockcroft-Gault formula\n* Ability to understand the nature of this study protocol and give written informed consent\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n* Participants with stage IV breast cancer\n* Participants currently taking statins\n* Uncontrolled hypertension (systolic blood pressure \\>190 mm Hg or diastolic blood pressure \\>100 mm Hg)\n* No active liver disease\n* Current use of CYP 3A4 inhibitors\n* Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he\u002Fshe were to participate in the study\n* Life expectancy \\\u003C 12 weeks\n* Pregnancy (positive pregnancy test) or lactation\n* Pre-existing sensory neuropathy \\> grade one\n* Has significant cardiovascular disease, such as:\n\nLVEF \\\u003C 50% at baseline as assessed by ECHO (preferred) i) Class III or Class IV myocardial disease as described by the New York Heart Association ii) Recent history (within 6 months prior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the time of randomization\n\n* Major surgery without complete recovery in the past four weeks prior to screening\n* Concurrent active infection\n* Participant with uncontrolled and\u002F or active infection with HIV, Hepatitis B or Hepatitis C\n* Participant who has a history of allergy or hypersensitivity to any of the study drugs\n* Participant with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis\n* Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study","FEMALE",{"count":56,"type":21},60,[58],"PHASE2","This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.",[29,61],"Early-stage Breast Cancer","2025-11-13",{"date":64,"type":38},"2025-11-14",{"date":66,"type":38},"2022-09-19",{"date":68,"type":21},"2027-03-01",{"name":70,"class":45},"Rutgers, The State University of New Jersey",10,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"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":80,"type":21},600,[24],"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.",[84,85,86,87,88,89,90,91,27,29,92,93,28],"Breast Cancer","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","Cancer Therapy-Related Cardiac Dysfunction",[95,88,96,97,98,84,28,99,100,101,102],"LCZ696","Magnetic Resonance Imaging","Echocardiography","Cardio-oncology","Anthracyclines","Trastuzumab","Heart failure","Cardioprotection","2025-03-11",{"date":105,"type":38},"2025-03-14",{"date":107,"type":38},"2024-04-17",{"date":109,"type":21},"2029-02",{"name":111,"class":45},"Silesian Centre for Heart Diseases",4,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100567157","cardiovascular-health-in-adult-patients-with-cancer-exposed-to-cardiotoxic-therapies-100567157","NCT06664528","Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies","Cardiovascular Health and Prognosis in Adult Patients With Cancer Exposed to Cardiotoxic Therapies, an Observational Study","CV_CANCER","Inclusion Criteria:\n\n* Patients over the age of 18 at the time of evaluation\n* Patients treated with potentially cardiotoxic anticancer drugs\n* Patients for which complete clinical, electrocardiographic and echocardiographic data are available at first evaluation and at least at one follow-up visit.\n\nExclusion Criteria:\n\n* Patients under the age of 18 at the time of evaluation\n* Patients whose documentation of the first visit is not available\n* Patients for whom it is not possible to obtain follow-up information through a medical visit or by telephone\n* Patient with poor acoustic window for echocardiographic examination.\n* Refusal of informed consent to participate in the study.",{"count":122,"type":21},300,"OBSERVATIONAL","The goal of this observational study is to evaluate the cardiovascular health and prognosis of adult patients with cancer, treated with cardiotoxic therapies.\n\nThe main purposes of the study are the following:\n\n* Identify the demographic factors related to the onset of cardiotoxicity produced by anticancer drugs.\n* Identify any subgroups more likely to develop distant major adverse cardiovascular events (MACE).\n* Evaluate the usefulness of clinical, biohumoral and echocardiographic parameters for early diagnosis of cardiotoxicity.\n\nParticipants will be monitored during the anticancer treatment via clinical, laboratory and instrumental evaluation according to the recommendation of the current guidelines on Cardio-Oncology (European Society of Cardiology, 2022). Initial follow-up will be 2 years.",[29,31],"2025-02-28",{"date":128,"type":38},"2025-03-04",{"date":126,"type":38},{"date":131,"type":21},"2028-12-15",{"name":133,"class":45},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",1,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":145,"studyType":123,"phases":4,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":134},"100459117","cor-loco-regional-advanced-lung-cancer-treated-with-chemo-radiotherapy-cola-100459117","NCT05258448","COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)","The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR","COLA","Inclusion Criteria:\n\n* Age ≥ 18 Years\n* Inoperable and histologically\u002Fcytologically verified NSCLC.\n* Planned treatment with curative intent.\n* Capable of completing study procedures ECG and Cardiac MR.\n* Able of giving written and informed consent before study procedures are initiated.\n\nExclusion Criteria:\n\n* Vulnerable patients.\n* Patients with operable devices as pacemaker\u002FICD and cochlear implant or other conditions where MR scan is contraindicated.\n* Claustrophobia.",{"count":144,"type":21},100,"2 Years","Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.",[29,148,149,150,151],"Lung Cancer Stage III","Lung Cancer Stage II","Radiation Toxicity","Cardiac Disease","2023-12-05",{"date":154,"type":38},"2023-12-06",{"date":156,"type":38},"2015-08",{"date":158,"type":21},"2026-10",{"name":160,"class":45},"Odense University Hospital"]