[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación para la Investigación del Hospital Clínico de Valencia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":299},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,58,84,108,128,148,174,200,230,255,277],{"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":30,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100629606","phase-4-effect-of-intravenous-iron-on-quality-of-life-in-older-patients-with-acute-coronary-syndrome-100629606",false,"NCT07476859","Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome","Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome","HI-COR-65","Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.\n3. Iron deficiency diagnosed at admission or within 15 days after the index ACS event, defined as:\n\n   * Serum ferritin \\\u003C 100 ng\u002FmL, OR\n   * Transferrin saturation (TSAT) \\\u003C 20%.\n4. Ability to provide written informed consent prior to participation.\n\nExclusion Criteria:\n\n1. Active malignancy.\n2. End-stage or terminal illness as determined by the IDC-Pal score.\n3. Known heart failure with left ventricular ejection fraction (LVEF) \\\u003C 40% prior to enrollment, or development of LVEF \\\u003C 40% during hospitalization or within 15 days after ACS.\n4. Chronic dialysis or advanced renal or hepatic failure.\n5. Severe anemia (hemoglobin \\\u003C 10 g\u002FdL) at the time of ACS or within 15 days after the event.\n6. Prior treatment with intravenous or oral iron within 12 months before the index ACS.\n7. Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.\n8. Evidence of iron overload or disorders of iron metabolism.\n9. Ongoing bacteremia or active systemic infection.\n10. Participation in another interventional clinical trial involving an investigational medicinal product.\n11. Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.","ALL","65 Years",{"count":20,"type":21},538,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this phase IV, open-label, randomized clinical trial is to evaluate whether intravenous iron improves quality of life in adults aged 65 years and older with iron deficiency after an acute coronary syndrome (ACS).\n\nThe main questions it aims to answer are:\n\n* Does intravenous iron improve quality of life at 6 and 12 months?\n* Does it reduce frailty and adverse clinical outcomes?\n\nResearchers will compare intravenous ferric carboxymaltose with standard of care.\n\nParticipants will:\n\n* Be randomly assigned to receive intravenous iron or standard care\n* Attend three study visits over 12 months\n* Complete questionnaires and undergo blood tests",[27,28,29],"Acute Coronary Syndromes (ACS)","Iron Deficiencies","Elderly (People Aged 65 or More)",[31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Acute coronary syndrome","Iron deficiency","Intravenous iron","Ferric carboxymaltose","Quality of life","Older adults","Myocardial infarction","Frailty","Cardiovascular outcomes","Biological aging","ELOVL2 methylation","Telomere length","Klotho","FGF23","RECRUITING","2026-03-20",{"date":48,"type":49},"2026-03-24","ACTUAL",{"date":51,"type":49},"2026-03-05",{"date":53,"type":21},"2028-05",{"name":55,"class":56},"Fundación para la Investigación del Hospital Clínico de Valencia","OTHER",9,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100560510","phase-3-a-clinical-trial-to-define-the-best-strategy-for-the-management-of-heart-failure-in-elderly-patients-100560510","NCT06578078","A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients","A Randomized Clinical Trial to Define the Best Strategy for the Management of Heart Failure and Chronic Kidney Disease Among Elderly Patients With or at High Risk of hyperKalemia in Span by Optimizing the Use of RAASi With SZC","SENEKA","Inclusion Criteria:\n\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Provision of informed consent form prior to any study specific procedures, sampling and analysis.\n* Individuals must be ≥ 70 years of age at the time of signing the informed consent form.\n* Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).\n* Individuals must have previously been admitted to hospital due to HF decompensation requiring intravenous diuretics.\n* Individuals must have been stabilised for at least 24-48h of their HF decompensation before randomisation.\n* Individuals must have a confirmed diagnosis of Chronic Kidney Disease defined as a renal impairment of eGFR less than 60ml\u002Fmin\u002F1.73 m2.\n* Individuals receiving background standard of care for HF and treated according to international guidelines. Specific treatment should include RAASi and\u002For MRA treatment and at least should have been stable for ≥ 4 weeks at maximum tolerated doses.\n* Patients on RAASi blocker treatment with less than or equal to 75% of the maximum recommended dose.\n* Hyperkalemic patients (sK+ 5.1-5.9 mmol\u002FL at screening \u002F study enrolment) or Normokalemic patients at risk of developing HK defining as having a history of hyperkalaemia (sK+ \\>5.0 mEq\u002FL) within the prior 24 months and sK+ ≥4.5 mEq\u002FL ≤ 5.1 mEq\u002FL at inclusion\n\nExclusion Criteria:\n\n* Limited life expectancy (less than 1 year) according to clinician's criteria, such as but not limited to malignancy, with life expectancy of less than 2 years based on investigator's clinical judgement.\n* sK \\>6 mEq\u002Flitre or \\\u003C4.5mEq\u002Flitre or history of hypokalemic episodes (S-K\\\u003C3.5 mEq\u002FL) during the last year.\n* Patients on haemodialysis or haemofiltration\n* NYHA functional class IV\n* Patients undergoing treatment with potassium binders.\n* Active tumour undergoing chemotherapy or metastasis or malignancy requiring treatment.\n* Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.\n* QTc(f) \\> 550 msec.\n* History of QT prolongation associated with other medications that required discontinuation of that medication.\n* Congenital long QT syndrome.\n* Prior history of hypersensitivity to a RAAS blocker drug, including but not limited to development of angioedema, icterus, hepatitis, or neutropenia or thrombocytopenia requiring treatment modification. Addison's disease or other causes of hypoaldosteronism.\n* Patients with a known hypersensitivity to SZC or any of the excipients of the product.\n* Individuals treated with potassium binding resins such as sodium polystyrene sulfonate (SPS, e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®) within 7 days prior to the first dose of study drug.\n* Treated with potassium supplements within 7 days prior to randomization. 15. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.\n* Known to have tested positive for human immunodeficiency virus.\n* Known history of drug or alcohol abuse within 3 year of screening.\n* Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).\n* Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.\n* Previous enrolment in the present study.\n* Participation in another clinical study with an investigational product during the last 3 months.","70 Years",{"count":68,"type":21},94,[70],"PHASE3","Heart failure (HF) and Chronic Kidney Disease (CKD) patients are frequently not administered renin-angiotensin aldosterone system inhibitor (RAASi) therapies at recommended doses due to hyperkalaemia, despite proven mortality and morbidity benefits. Sodium zirconium cyclosilicate (SZC) is a nonabsorbed potassium binder proven to lower serum potassium (S-K) and maintain normokalaemia. The purpose is to assess if a treatment regimen containing SZC will allow RAASi therapies to be optimized to target doses in patients with heart failure, chronic kidney disease and elevated serum potassium or at risk of developing elevated serum potassium.",[73,74],"Heart Failure","Chronic Kidney Diseases","2026-03-02",{"date":77,"type":49},"2026-03-04",{"date":79,"type":49},"2024-10-03",{"date":81,"type":21},"2026-12-30",{"name":55,"class":56},6,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100592335","short-of-pace---heart-failure-shop-hf-100592335","NCT06992089","SHort Of Pace - Heart Failure (SHOP-HF)","Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial","Inclusion Criteria:\n\n* Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.\n* Diagnosis criteria of HFpEF according to ESC guidelines:\n\n  1. symptoms and signs of HF.\n  2. left ventricular ejection fraction ≥50% by Simpson method.\n  3. proBNP \\>125 pg\u002FmL in the last month.\n  4. at least one additional criterion: 1. relevant structural heart disease (left ventricular hypertrophy and\u002For left atrial enlargement); and\u002For 2. Diastolic dysfunction.\n* Left ventricular hypertrophy was defined as wall thickness \\> 10 mm.\n* Small ventricular volume was defined as indexed left ventricular end diastolic volume \\\u003C 45 ml\u002Fm2.\n* Adults ≥18 years old.\n* Previous admission for acute heart failure.\n* Chronotropic incompetence assessed by CPET, defined as: \\[(HRmax - HRrest)\\]\u002F\\[(220 - age) - (HRrest)\\] \\\u003C 0.62.\n* Resting heart rate \\\u003C 65 bpm in sinus rhythm or 70 bmp in atrial fibrillation.\n\nExclusion Criteria:\n\n* Inability to perform a valid baseline exercise test.\n* Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease.\n* Patient with prior history of left ventricular ejection fraction \\\u003C50%.\n* History of an acute coronary syndrome in the previous 12 months.\n* Effort angina or signs of ischemia during CPET.\n* RER threshold at \\\u003C1.05 at the CPET.\n* Significant primary moderate to severe valvular disease.\n* Any other comorbidity with a life expectancy lower than 1 year.\n* Heart rate at rest \\> 75 lpm.\n* Other pacemaker indication.\n* Pregnant women.\n* Baseline rhythm different from sinus rhythm or atrial fibrillation.\n* Active treatment with beta-blockers, digitalis or non dihidropiridine calcium channel blockers.","18 Years",{"count":93,"type":21},30,[95],"NA","This study is designed as a multicenter, prospective, controlled, randomized, two-arms, cross-over, two parallel cohorts, efficacy Clinical research with CE-marked medical device . The crossover trial will be performed in a blind fashion, so each participant will be evaluated during both blinded pacing-on and pacing-off phases, each of which will last 3 months. The population includes patients with the diagnosis of stable HFpEF according to criteria of the European Society of Cardiology and New York Heart Association (NYHA) functional class II-III\u002FIV, left ventricular hypertrophy with small ventricular volume, sinus rhythm with low basal heart rate and chronotropic incompetence (CI).\n\nAll patients will undergo pacemaker implantation, and computer-generated randomization sequence previously designed will be used to allocate participants (in a 1:1 ratio) to receive: (a) programming of the pacemaker with pacing On followed by pacing Off in two periods of 3 months; or (b) programming of the pacemaker with pacing Off followed by pacing On in two periods of 3 months. The study will be conducted in three centers in Spain. Discounting the time due to staggered entry, the total duration of a patient's follow-up will be 7 months.",[98],"Heart Failure With Preserved Ejection Fraction","2025-12-05",{"date":101,"type":49},"2025-12-12",{"date":103,"type":49},"2025-06-17",{"date":105,"type":21},"2026-06",{"name":55,"class":56},1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":107},"100560543","phase-4-effect-of-the-use-of-dapagliflozin-in-patients-with-refractory-heart-failure-100560543","NCT06578520","Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure","Effect of the Use of Dapagliflozin in Diuresis, Natriuresis and in Ultrafiltration and Peritoneal Elimination of Sodium, in Patients With Refractory Heart Failure","Inclusion Criteria:\n\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Provision of informed consent form prior to any study specific procedures, sampling and analysis.\n* Individuals must be ≥ 18 years of age at the time of signing the informed consent\n* Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).\n* In treatment with Peritoneal Dialysis technique\n* Chronic Kidney Disease (eGFR \\\u003C 60 ml\u002Fmin\u002Fm2 CKD-EPI formula)\n* PD vintage of more than 30 days\n* On stable doses of furosemide, or alternative loop diuretic for 14 days\n* On stable HF therapy for at least 1 month prior to consent\n* No hospitalizations for HF for at least 1 month prior to consent\n\nExclusion Criteria:\n\n* Limited life expectancy (less than 1 year) based on investigator's clinical judgement.\n* Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information.\n* Malignancy (with active treatment) or other life-threatening disease\n* Patients in whom proper study compliance cannot be guaranteed\n* Rejection or revocation of informed consent\n* Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 1 month prior to enrollment.\n* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair\u002Freplacement) within 1 month prior to enrollment or planned to undergo any of these operations after randomization.\n* Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 1 month prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.\n* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization\n* Pregnant or breast-feeding women\n* Type 1 Diabetes\n* Residual urine volume less than 500ml daily or reduction in urinary output by 24 hours (\\\u003C 30% compared to previous routine control) within 30 days prior to consent\n* Patients with amputated limbs will be excluded of bioimpedance analysis.\n* Participation in another clinical study with an investigational product during the last 3 months.\n* Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product.\n* Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).\n* Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.\n* Previous enrolment in the present study.",{"count":116,"type":21},31,[24],"Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.",[73],"2025-08-05",{"date":122,"type":49},"2025-08-06",{"date":124,"type":49},"2024-07-30",{"date":126,"type":21},"2025-12-31",{"name":55,"class":56},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100560837","is-the-3d-panc-msp-model-superior-to-ct-for-assessing-response-to-neoadjuvant-treatment-in-pca-patients-100560837","NCT06582342","Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?","Is 3-D Imaging Technology Superior to Computed Tomography in Assessing Response to Neoadjuvant Treatment in Patients With Borderline or Locally Advanced Pancreatic Adenocarcinoma?","Inclusion Criteria:\n\n\\- Patients with a diagnosis of borderline or locally advanced PAC of the head of the pancreas, as defined by the National Comprehensive Cancer Network (NCCN), who have received neoadjuvant treatment and who undergo surgical exploration with resective intent.\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age.\n* Patients under 18 years of age.\n* Disease progression during neoadjuvant treatment.\n* No preoperative CT scan.\n* Refusal to participate in the study.",{"count":136,"type":21},70,"OBSERVATIONAL","Prospective multicenter study in which all patients with borderline or locally advanced pancreatic adenocarcioma undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year. Preoperative images by traditional CT and 3D-MSP technology will be evaluated, comparing the accuracy variables (sensitivity, specificity, predictive values, area under the curve, concordance index) of both techniques with the gold standard (results of surgery and histopathological analysis).",[140],"Adenocarcinoma of the Pancreas",{"date":122,"type":49},{"date":143,"type":49},"2024-03-21",{"date":145,"type":21},"2025-12-30",{"name":55,"class":56},17,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":156,"minAge":91,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":173,"locationsCount":107},"100516246","evaluation-of-improvements-in-patient-reported-quality-of-life-100516246","NCT06002022","Evaluation of Improvements in Patient-reported Quality of Life","Local Intervention Trial for the Evaluation of Improvements in Patient-reported Quality of Life and Treatment Satisfaction in BCP as a Result of Flexible Treatment Planning Supported by REBECCA-collected RWD","REBECCA-QoL","Inclusion Criteria:\n\n* Before patient registration, written informed consent must be given according to national and local regulations.\n* Participants have had histologically proven stage I-III breast cancer undergoing endocrine treatment (with or without prior chemotherapy) no more than 12 months prior to randomization.\n* Be between 18 and 75 years of age.\n* Have increased life expectancy beyond the initial 3 months post-treatment initiation.\n* Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Patients that are not willing to sign an informed consent form","FEMALE","75 Years",{"count":159,"type":21},110,[95],"Local intervention trial for the evaluation of improvements in patient-reported Quality of Life and treatment satisfaction, in breast cancer patients (BCP), as a result of flexible treatment planning supported by REBECCA-collected real-world data, in comparison with standard care",[163,164,165,166,167,168],"Breast Cancer","Quality of Life","Physical Activity","Sleep Quality","Stress","Pain",{"date":122,"type":49},{"date":171,"type":49},"2024-01-01",{"date":126,"type":21},{"name":55,"class":56},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":182,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":107},"100548463","personalised-health-recommendations-to-the-general-population-through-an-integrated-ai-guided-100548463","NCT06421324","Personalised Health Recommendations to the General Population Through an Integrated AI Guided","Interventional Study Focused on Providing Personalised Health Recommendations to the General Population Through an Integrated AI Guided App as a Strategy for Gastric Cancer Prevention (AIDA)","AIDA","Inclusion Criteria:\n\n* Subjects ≥ 18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care\n* Availability of a signed informed consent form to participate in the study\n\nExclusion Criteria:\n\n* Patients to whom an endoscopy is performed for the follow-up of another illness such as oesophageal varices and\u002For for therapy such as endoscopic dilation, feeding tube placement or endoscopic resection\n* Subjects with a clinical diagnosis of gastric diseases other than GIM or GC\n* Patients who have received antimicrobials during the four weeks prior to the endoscopy\n* Patients who have received proton pump inhibitors and\u002For bismuth-based treatments at least two weeks prior to the endoscopy\n* Subjects for whom clinical data are not available: H. pylori status, eradication treatment, sex, age, tobacco smoking, and first-degree family history of gastric cancer\n* Subjects who lack the mental capacity to understand the nature and requirements of the study and who lack the ability to give informed consent",true,{"count":184,"type":21},450,[95],"This clinical study aims to be used to implement and validate the AIDA tool in two phases:\n\n* Phase 1: Risk stratification and personalised recommendations \\& Model development\n* Phase 2: Mechanistic Model (Bioresource) development \\& testing",[188,189,190,191],"Gastric Cancer","Cancer Prevention","Helicobacter Pylori Infection","Artificial Intelligence","2025-02-25",{"date":194,"type":49},"2025-02-27",{"date":196,"type":49},"2024-06-01",{"date":198,"type":21},"2026-12-31",{"name":55,"class":56},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":156,"minAge":208,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":107},"100566465","effects-of-an-exercise-program-in-women-over-60-yr-with-hfpef-and-sarcopenia-on-functional-capacity-and-quality-of-life-100566465","NCT06655532","Effects of an Exercise Program in Women Over 60 yr. With HFpEF and Sarcopenia on Functional Capacity and Quality of Life","Effects of a Concurrent Training-based Exercise Program in Women Over 60 Years With Heart Failure With Preserved Ejection Fraction and Sarcopenia on Functional Capacity, Quality of Life and Cognitive Function","TRAIN-SARC","Inclusion Criteria:\n\n* Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure, with N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>125 pg\u002FmL, inthe last month.\n* Stable symptomatic heart failure patients (New York Heart Association functional class II-III) during the last month.\n* Age ≥ 60 years old.\n* The participant is willing to give informed consent to participate in the study.\n* SARC-F score ≥4 points.\n\nExclusion Criteria:\n\n* Inability to perform a valid baseline cardiopulmonary exercise test.\n* Cardiac pacemaker.\n* Significant primary moderate-to-severe valve disease.\n* Effort angina or signs of ischemia during CPET.\n* Primary cardiomyopathies.\n* Cardiac transplantation.\n* Any other comorbidity with a life expectancy of less than one year.","60 Years",{"count":210,"type":21},40,[95],"This prospective study will randomize (1:1) women with heart failure with preserved ejection fraction (HFpEF) and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program (combining aerobic and strength exercise) carried out in a single centre.\n\nAfter randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Women over 60 with HFpEF, functional class NYHA class II-III, and sarcopenia criteria will be enrolled. A sample size estimation \\[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +1.9 mL\u002Fkg\u002Fmin (SD±2)\\] of 40 patients (20 per arm) would be necessary to test our hypothesis.",[214,215,216],"Heart Failure With Preserved Ejection Fraction (HFpEF)","Sarcopenia","Women",[218,215,219,220,73,216],"Heart Failure with Preserved Ejection Fraction","Cardiovascular Diseases","Heart Diseases","NOT_YET_RECRUITING","2024-10-23",{"date":224,"type":49},"2024-10-26",{"date":226,"type":21},"2024-11-04",{"date":228,"type":21},"2026-01-30",{"name":55,"class":56},{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":107},"100565281","effects-of-a-supervised-training-program-on-functional-capacity-in-patients-with-hf-and-cardiorenal-syndrome-100565281","NCT06640140","Effects of a Supervised Training Program on Functional Capacity in Patients With HF and Cardiorenal Syndrome","Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Cardiorenal Syndrome","Train-CR","Inclusion Criteria:\n\n* Patients diagnosed with heart failure according to 2021 ESC guidelines for Heart Failure.\n* Evidence of cardiorenal syndrome, defined as coexistent very high risk chronic kidney disease (CKD) (estimated glomerular filtration rate \\[eGFR\\] \\<30 ml\u002Fmin\u002F1.73m2 or eGFR 30 to 44 ml\u002Fmin\u002F1.73m2 and Urine Albumin-Creatinine Ratio \\[uACR\\] \\>30 mg\u002Fg) or rapidly progressive CKD (loss of \\>5 ml\u002Fmin\u002F1.73m2 in one year).\n* Stable symptomatic heart failure patients (New York Heart Association functional class II-III\u002FIV) during the last month.\n* Age ≥ 18 years old.\n* Willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Inability to perform a valid baseline cardiopulmonary exercise test.\n* Significant primary severe valve disease that is considered the main symptom driver.\n* Effort angina or signs of ischemia during CPET.\n* Primary cardiomyopathies.\n* Cardiac transplantation.\n* Any other comorbidity with a life expectancy of less than one year.",{"count":239,"type":21},26,[95],"This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation \\[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL\u002Fkg\u002Fmin (SD±2)\\] of 26 patients (13 per arm) would be necessary to test our hypothesis.",[73,243],"Cardiorenal Syndrome",[245,243,246],"Heart failure","Functional Capacity","2024-10-10",{"date":249,"type":49},"2024-10-15",{"date":251,"type":21},"2024-10-08",{"date":253,"type":21},"2025-12",{"name":55,"class":56},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},"100560509","colorectal-anastomosis-outcomes-using-the-novel-powered-circular-stapler-compared-with-manual-circular-staplers-100560509","NCT06578065","Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.","Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.","Inclusion Criteria:\n\n* Patient or its legal representative informed consent.\n* Age ≥ 18 years.\n* Patients who will undergo a colorectal anastomosis after left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology (NOTE: Hartmann reversal cases also included).\n\nExclusion Criteria:\n\n* Diverting stoma.\n* Emergency surgery.\n* American Society of Anaesthesiologists (ASA) score ≥ IV.\n* Transanal total mesorectal excision approach.",{"count":263,"type":21},540,[95],"Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms:\n\n* ECPS group: Echelon Circular™ Powered Stapler (n=270)\n* MCS Group: manual circular staplers (n=270) Patients will be followed during 30 days in order to evaluate the primary endpoint.",[267],"Colorectal Anastomosis","2024-08-30",{"date":270,"type":49},"2024-09-04",{"date":272,"type":49},"2024-06-27",{"date":274,"type":21},"2026-09-01",{"name":55,"class":56},4,{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100560544","phase-3-keeping-raasi-treatment-with-optimal-potassium-control-100560544","NCT06578533","Keeping RAASi Treatment With Optimal Potassium Control","Phase III, Multicenter, Open-label, Randomized Clinical Trial to Evaluate Efficacy of Sodium Zirconium Cyclosilicate (Lokelma) Compared to Standard of Care to Manage Hyperkalemia in Patients With Chronic Kidney Disease (CKD)","KEEP-ON","Inclusion Criteria:\n\n* Patients must present serum potassium levels of 5.5-6.5 mEq\u002FL at patient selection visit (V0)\n* Patients must present serum potassium levels of 5.0-6.5 mEq\u002FL at randomization visit (V1).\n* Provision of patient or legal representative informed consent prior to any study specific procedures.\n* Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include RAASi and\u002For MRA treatment at first consultation and at least should have been stable for ≥ 4 weeks at maximum tolerated doses.\n* Patients with CKD not on dialysis (Stages 2-5: estimated glomerular filtration rate (eGFR) between 15-60 ml\u002Fmin\u002F1,73m2 or eGFR between 60-90 ml\u002Fmin\u002F 1.73 m2 with albuminuria\u002Fcreatinuria (\\> 30 mg\u002Fg) in the previous three months). The estimated GFR can be reported by the laboratory or calculated by the researcher with serum creatinine, age, and sex (CKD-EPI equation).\n* 18 years at the time of signing ICF.\n* Negative pregnancy test (urine or serum) for female subjects of childbearing potential.\n* Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign ICF) and for 3 months after the last dose of SZC. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.\n\nExclusion Criteria:\n\n* Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).\n* Previous enrollment or randomization in the present study.\n* HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.\n* Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment.\n* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair\u002Freplacement within 12 weeks prior to enrollment or planned to undergo any of these operations after randomization).\n* Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.\n* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization\n* Oropharingeal dysfunction that precludes normal swallow.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.\n* Patients with amputated limbs or pacemaker devices will be excluded of bioimpedance analysis.\n* Participation in another clinical study with an investigational product during the last 6 months.\n* Patients with a known hypersensitivity to SZC or any of the excipients of the product.\n* Treated with potassium binding resins such as sodium polystyrene sulfonate (SPS; e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®), within 7 days prior to the first dose of study drug.\n* Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.\n* Subjects with a family history of long QT syndrome, presence of cardiac arrhythmias or conduction defects that require immediate treatment, or a QTc (corrected QT interval) of ≥ 550 msec.\n* History of QT prolongation associated with other medications that required discontinuation of that medications.\n* Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.",{"count":286,"type":21},78,[70],"Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation\u002Freduction and\u002For ARM (standard treatment).",[74],"2024-08-27",{"date":292,"type":49},"2024-08-29",{"date":294,"type":49},"2022-09-30",{"date":296,"type":21},"2026-07-30",{"name":55,"class":56},5,""]