[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-ischemic-dilated-cardiomyopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-ischemic-dilated-cardiomyopathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,75,110,134,156],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100573526","high-fat-diet-for-cardiac-metabolic-reprogramming-100573526",false,"NCT06747429","High Fat Diet for Cardiac Metabolic Reprogramming","Cardiac Metabolic Reprogramming by a Nutritional Intervention: the High Fat Diet for Heart Failure (HF4HF) Study, a proof-of Concept Randomized Controlled Trial","HF4HF","Inclusion Criteria:\n\n* Patients of both sexes and ≥18 years old\n* Patients diagnosed with HF secondary to non-ischemic DCM, according to ESC guidelines definition,1 with or without a known genetic basis.\n* LVEF ≤49% according to the baseline CMR.\n* Optimized HF guideline-directed medical therapy for at least 3 months prior to inclusion.\n* Patients who have provided informed consent.\n\nExclusion Criteria:\n\n* Prior diagnosis of ischemic DCM.\n* Prior diagnosis of established atherosclerotic cardiovascular disease (angina\u002Fmyocardial infarction, transient ischemic attack\u002Fstroke, lower limb ischemia or at any other peripheral level).\n* Changes in HF therapies within the last 3 months.\n* HF decompensation within the previous 3 months, including HF hospitalization or the need of ambulatory intravenous diuretic or inotropic treatment such as levosimendan.\n* Uncontrolled dyslipidemia, defined as LDL-cholesterol \\>160 mg\u002FdL and\u002For triglycerides \\>200 mg\u002FdL, despite treatment.\n* Any contraindication for CMR:\n\nSevere claustrophobia. Any device which is known to threaten or pose hazard in all MR environments. \u002F\u002Fwww.mrisafety.com\u002F Patients with implanted biomedical devices (cardiac artefacts): pacemakers, cardiac defibrillators or cardiac resynchronization therapy.\n\n* Liver and biliary diseases, including prior diagnosis of non-alcoholic fatty liver disease and unoperated cholelithiasis.\n* Prior episodes of acute pancreatitis or chronic pancreatitis.\n* Prior fish or nut allergy.\n* Life expectancy less than 12 months.\n* Pregnancy or planned pregnancy for the next 4 months.\n* Current lactation.\n* Patients participating in other randomized clinical trial.\n* Impossibility to consent or undergo study follow-up","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","Heart failure (HF) continues to be a leading cause of morbidity and mortality worldwide, despite advances in treatment. HF is often characterized by an altered metabolism in the heart, where glucose is favored over fatty acids as the primary energy substrate. This metabolic shift has been hypothesized to contribute to disease progression. Previous studies using animal models have demonstrated that restoring fatty acid metabolism through dietary intervention can reverse the adverse metabolic effects and improve heart function. A transgenic murine model with mitochondrial defects, for instance, exhibited improved cardiac function after an HFD intervention. These findings were reinforced by a translational pig model of non-ischemic DCM, where a high-fat diet significantly improved LVEF compared to a standard diet.\n\nBuilding upon these promising preclinical results, a small-scale human study showed that lipid infusion, rather than glucose, improved cardiac function in HF patients. However, the long-term benefits of a HFD in heart failure patients have yet to be thoroughly explored. The HF4HF trial aims to fill this gap by evaluating the effects of an HFD over a two-month period in patients with non-ischemic DCM and reduced LVEF.\n\nThe \"High Fat Diet for Heart Failure\" (HF4HF) study is a proof-of-concept randomized controlled trial designed to investigate the efficacy of a high-fat diet (HFD) as a therapeutic intervention in patients with non-ischemic dilated cardiomyopathy (DCM) and reduced left ventricular ejection fraction (LVEF). The study hypothesizes that cardiac metabolic reprogramming, achieved through a controlled nutritional intervention involving an HFD, can enhance systolic function, myocardial energetics, and overall heart function in heart failure (HF) patients. Cofunded by the European Commission and national entities, the trial is spearheaded by a consortium of cardiovascular research centers across four countries: Spain, Italy, France, and Romania.",[27,28],"Non-ischemic Dilated Cardiomyopathy","Heart Failure With Reduced Ejection Fraction",[30,31,32,33],"heart failure","high-fat diet","clinical trial","non-ischemic DCM","RECRUITING","2026-05-21",{"date":37,"type":38},"2026-05-26","ACTUAL",{"date":40,"type":38},"2026-01-15",{"date":42,"type":21},"2026-12",{"name":44,"class":45},"Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III","OTHER",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100399109","phase-2-administration-of-allogeneic-msc-in-patients-with-non-ischemic-dilated-cardiomyopathy-100399109","NCT04476901","Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy","A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Administration of Allogeneic-MSC Versus Placebo in Patients With Non- Ischemic Dilated Cardiomyopathy","DCMII","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form.\n2. Diagnosis of NIDCM with left ventricular ejection fraction ≤45%.\n3. Appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy. At a minimum, subjects must be on beta blockers and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical indication precluding use of one or both of these agents. Subjects must be on a stable regimen for at least 30 days prior to the procedure. Dose titration is allowed.\n4. Be a candidate for cardiac catheterization\\*\n5. Be willing to undergo DNA test.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of non-ischemic dilated cardiomyopathy\n2. Clinical manifestation of coronary artery disease (CAD) (e.g., chest pain and concomitant clinical findings such as electrocardiogram changes suggestive of coronary ischemia, myocardial infarction) or evidence of endocardial or transmural scar on cardiac MRI suggestive of undiagnosed CAD or history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Be indicated for or require coronary artery revascularization\n3. Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries\n4. Valvular heart disease including 1) aortic valve prosthesis, mechanical mitral valve, and mitral valve clip; 2) severe aortic valve insufficiency\u002Fregurgitation within 12 months of consent\\*\n5. Aortic stenosis with valve area ≤ 1.5cm2\\*\n6. Cardiomyopathy due to acute Post-partum (within 6 months), Non-compaction\\*, or Hypertrophic\\* cardiomyopathy\n7. Cardiomyopathy due to known toxin (e.g amyloid) Note: anthracycline induced cardiomyopathy will be allowed\n8. QTc interval \\> 550 ms on baseline electrocardiogram (ECG) (note: QTc interval is the interval between the start of the Q wave and the end of the T wave in the heart's electrical cycle)\n9. Automated Implantable Cardioverter Defibrillator (AICD) appropriate firing or anti tachycardia pacing for ventricular tachycardia or ventricular fibrillation within 30 days prior to consent\n10. Have an estimated baseline glomerular filtration rate below the clinical site's institutional cutoff\n11. A hematologic abnormality during baseline testing as evidenced by hemoglobin \\\u003C 9 g\u002Fdl; hematocrit \\\u003C 30%; absolute neutrophil count \\\u003C 2,000 or total WBC count more than 2 times upper limit of normal; or platelet values \\\u003C 100,000\u002Ful\n12. Have liver dysfunction, as evidenced by enzymes Aspartate Transaminase Enzyme (AST) and Alanine Aminotransferase Enzyme (ALT) greater than three times the ULN\n13. Have a bleeding diathesis or coagulopathy (International Normalised Ratio (INR) \\> 1.5), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions\n14. Be a solid organ transplant recipient. This does not include prior cell based therapy (\\>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.\n15. Have a history of organ or cell transplant rejection\n16. Have a clinical history of malignancy within the past 12 months (i.e., subjects with prior malignancy must be disease free for 12 months), except curatively treated basal cell or squamous cell carcinoma or cervical carcinoma\n17. Drug and\u002For alcohol abuse or dependence within the past 9 months\n18. Be serum positive for HIV, hepatitis B surface antigen, or viremic hepatitis C\n19. Documented presence of a known Left Ventricular (LV) thrombus, aortic dissection, or aortic aneurysm. (Refer to \"Guidance to the PI\" section with regards to LV thrombus, below)\\*\n20. Blood glucose levels (HbA1c) \\>10%\n21. Severe radiographic contrast allergy\n22. Known history of anaphylactic reaction to penicillin or streptomycin\n23. Hypersensitivity to dimethyl sulfoxide (DMSO)\n24. Non-cardiac condition with life expectancy \\\u003C 1 year\n25. Acute stroke or transient ischemic attack within 3 months of enrollment\n26. Be pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods\n27. Pacemaker-dependence with an Implantable Cardioverter Defibrillator (ICD) (Note: pacemaker-dependent candidates without an ICD are not excluded)\n28. Presence of a pacemaker and\u002For ICD generator with any of the following limitations\u002Fconditions:\n\n    * manufactured before the year 2000\n    * leads implanted \\\u003C 6 weeks prior to consent\n    * non-transvenous epicardial or abandoned leads\n    * subcutaneous ICDs\n    * leadless pacemakers\n29. A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent\n30. Other MRI contraindications (e.g. subject body habitus incompatible with MRI)\n31. Need for advanced heart failure therapy (e.g. IV inotropes)\n32. Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial\n33. Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up\n\n(\\*) Applies to subjects receiving product via transendocardial administration only","80 Years",{"count":57,"type":21},136,[59],"PHASE2","The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.",[27],[63,64],"Allogeneic mesenchymal stem cells","Bone marrow-derived mesenchymal stem cells","2026-03-20",{"date":67,"type":38},"2026-03-24",{"date":69,"type":38},"2021-05-07",{"date":71,"type":21},"2027-04",{"name":73,"class":45},"Joshua M Hare",4,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100498344","conventional-biventricular-versus-left-bundle-branch-pacing-on-outcomes-in-heart-failure-patients-100498344","NCT05769036","Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients","Randomized Study of Integrated Evaluation of Conventional Biventricular and Left Bundle Branch Pacing Therapy Effect on Left Ventricular Remodeling and Clinical Outcomes in Patients With Chronic Heart Failure With Reduced Ejection Fraction","RECOVER-HF","Inclusion criteria:\n\n1. The patient is willing and able to comply with the protocol and has provided written informed consent;\n2. Male or female patients aged 18 to 80 years;\n3. Patients with ischemic or non-ischemic cardiomyopathy;\n4. Symptomatic HF for at least 3 months prior to enrollment in the study;\n5. New York Heart Association (NYHA) functional class HF ≥ II;\n6. Patients with HF in sinus rhythm (SR) with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with LBBB morphology;\n7. Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration 130-149 ms with LBBB morphology;\n8. Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with non-LBBB morphology;\n9. Patients with symptomatic persistent or permanent atrial fibrillation, HF with LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) and an uncontrolled heart rate who are candidates for atrioventricular junction ablation (irrespective of QRS duration);\n10. Patients with HF, LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) and indications for continuous ventricular pacing due to bradycardia;\n11. Patients who have received a conventional pacemaker or an implanted cardioverter-defibrillator and who subsequently develop symptomatic HF with LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) despite optimal medical therapy, and who have a significant proportion of right ventricle pacing;\n12. Optimal HF medical therapy.\n\nExclusion criteria:\n\n1. Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;\n2. Acute myocardial infarction within 3 months prior to enrollment;\n3. Acute coronary syndrome;\n4. Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);\n5. Patients listed for heart transplant;\n6. Patients with implanted cardiac assist device;\n7. Acute myocarditis;\n8. Infiltrative myocardial disease;\n9. Hypertrophic cardiomyopathy;\n10. Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;\n11. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;\n12. Mental or physical inability to participate in the study;\n13. Patients unable or unwilling to cooperate within the study protocol;\n14. Patients with rheumatic heart disease;\n15. Mechanic tricuspid valve patients;\n16. Patients with any serious medical condition that could interfere with this study;\n17. Enrollment in another investigational drug or device study;\n18. Patients not available for follow-up;\n19. Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml\u002Fmin\u002F1.73 m2);\n20. Life expectancy ≤ 12 months;\n21. Participation in another telemonitoring concept.",{"count":84,"type":21},60,[24],"Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of cardioresynchronization device using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Subsequently, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has showed greater improvement in hemodynamic parameters than with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to biventricular CRT. This method has become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS duration. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP in patients with CRT indications. However, it is not enough data about CRT with LBBP effectiveness in LV remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP compared with conventional biventricular CRT will significantly improve the clinical outcomes and reverse LV remodeling in patients with chronic HF with reduced LV ejection fraction and reduce the number of non-responders to conventional CRT.",[88,89,90,27,91,92,93],"Heart Failure","Left Bundle-Branch Block","Ischemic Cardiomyopathy","Left Ventricular Dysfunction","Left Ventricular Dyssynchrony","Left Ventricle Remodeling",[95,96,97,98,99],"Cardiac Resynchronization Therapy","Biventricular Pacing","Left Bundle Branch Pacing","Speckle Tracking Echocardiography","Biomarker of Fibrosis and Remodeling","2025-09-03",{"date":102,"type":38},"2025-09-10",{"date":104,"type":38},"2023-10-01",{"date":106,"type":21},"2028-09-01",{"name":108,"class":45},"Tomsk National Research Medical Center of the Russian Academy of Sciences",1,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":133,"locationsCount":109},"100497721","left-bundle-branch-pacing-on-outcomes-and-ventricular-remodeling-in-biventricular-crt-nonresponders-100497721","NCT05760924","Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders","Randomized Trial of Left Bundle Branch Pacing Effect on Clinical Outcomes and Left Ventricular Remodeling in Patients With Nonresponse to Biventricular Cardiac Resynchronization Therapy","RESCUE","Inclusion criteria:\n\n1. The patient is willing and able to comply with the protocol and has provided written informed consent;\n2. Male or female patients aged 18 to 80 years;\n3. Patients with ischemic or non-ischemic cardiomyopathy;\n4. Symptomatic HF for at least 3 months prior to enrollment in the study;\n5. New York Heart Association (NYHA) functional class HF ≥ II;\n6. Patients who are non-responders to biventricular CRT with HF, reduced LVEF and CRT-D replacement or one of the CRT-D leads replacement indications (without LVEF increase ≥ 5% and\u002For without a left ventricle end-systolic volume decrease ≥ 15% after CRT-D implantation at least 1 year old);\n7. Optimal HF medical therapy.\n\nExclusion criteria:\n\n1. Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;\n2. Acute myocardial infarction within 3 months prior to enrollment;\n3. Acute coronary syndrome;\n4. Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);\n5. Patients listed for heart transplant;\n6. Patients with implanted cardiac assist device;\n7. Acute myocarditis;\n8. Infiltrative myocardial disease;\n9. Hypertrophic cardiomyopathy;\n10. Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;\n11. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;\n12. Mental or physical inability to participate in the study;\n13. Patients unable or unwilling to cooperate within the study protocol;\n14. Patients with rheumatic heart disease;\n15. Mechanic tricuspid valve patients;\n16. Patients with any serious medical condition that could interfere with this study;\n17. Enrollment in another investigational drug or device study;\n18. Patients not available for follow-up;\n19. Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml\u002Fmin\u002F1.73 m2);\n20. Life expectancy ≤ 12 months;\n21. Participation in another telemonitoring concept.",{"count":119,"type":21},30,[24],"Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with the increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of device for cardiac resynchronization therapy using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Cardiac conduction system pacing is currently a promising technique for these patients. Particularly, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has shown greater improvement in hemodynamic parameters comparing with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP, especially high pacing threshold. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to conventional biventricular CRT. Also, since 2019, left bundle branch pacing-optimized CRT (LBBPO CRT) has been used in clinical practice. These methods have become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS complex duration on electrocardiogram. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP and LBBPO CRT in patients with CRT indications. However, it is not enough data about impact of CRT with LBBP and combined CRT with LBBP and LV pacing on myocardial remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP and combined CRT with LBBP and LV pacing compared with conventional biventricular pacing will significantly improve the clinical outcomes and reverse myocardial remodeling in patients who are non-responders to biventricular CRT with HF, reduced LV ejection fraction and with indications to CRT devices with defibrillator function (CRT-D) or one of the CRT-D leads replacement.",[88,89,90,27,91,93],[95,96,97,98,99,124,125,126],"Combined Left Bundle Branch and Left Ventricular Pacing","CRT Non-responder","CRT Responder","2024-11-20",{"date":129,"type":38},"2024-11-22",{"date":131,"type":38},"2024-11-01",{"date":106,"type":21},{"name":108,"class":45},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":109},"100405388","cardiac-magnetic-resonance-guidance-of-implantable-cardioverter-defibrillator-implantation-in-non-ischemic-dilated-cardiomyopathy-100405388","NCT04558723","Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy","Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy","CMR-ICD","Inclusion Criteria:\n\n* NIDCM (idiopathic or familial)\\*\n* LVEF ≤35% and presence of fibrosis on CMR\n* Diagnostic CMR scan\n* Age ≥18 years\n* Written informed consent\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* ICM \\[previous myocardial infarction, previous percutaneous coronary intervention\\]\n* Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies \\[e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy\\], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies \\[Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy\\].\n* Myocarditis\n* Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium)\n* Severe renal insufficiency (creatinine clearance \\\u003C30 mL\u002Fmin)\n* Current pacemaker or defibrillator in situ\n* Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD)\n* Renal impairment defined as an eGFR \\\u003C30 milliliters\n* Age \\\u003C18 years\n* Patients presenting with pregnancy\n* Patients without informed consent\n* Participation in another randomized trial\n* Life expectancy \\\u003C2 years",{"count":143,"type":21},760,[24],"Patients with diagnostic CMR images for assessment of LGE\u002Ffibrosis and evidence\u002Fpresence of non-ischaemic myocardial fibrosis\u002Fscar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.",[27],"2024-05-10",{"date":149,"type":38},"2024-05-13",{"date":151,"type":38},"2021-01-14",{"date":153,"type":21},"2027-11",{"name":155,"class":45},"Prof. Dr. med. Ingo Eitel",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":177},"100520356","study-of-personalized-allocation-of-defibrillators-in-non-ischemic-heart-failure-spanish-1-100520356","NCT06055504","Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of screening.\n* Previously established diagnosis of Non-ischemic DCM\n* Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.\n* NYHA functional class II-III.\n* LVEF ≤ 35% documented by CMR as study procedure.\n* Life expectancy greater than 12 months.\n\nExclusion Criteria:\n\n* History of coronary artery disease justifying the presence of ventricular dysfunction, defined as: history of coronary revascularisation or presence of significant coronary stenosis (≥50% in left main or ≥70% in a major epicardial artery) on invasive or non-invasive coronary angiography (coronary CT)\n* Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.\n* Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.\n* History of recovered sudden death or sustained ventricular tachycardia.\n* NYHA functional class IV.\n* Waiting list for cardiac transplantation in emergency 0.\n* Receiver of a solid organ transplant (lung, liver, heart or kidney).",{"count":163,"type":21},900,[24],"Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for Sudden Cardiac Death (SCD) prevention in patients with non-ischemic dilated cardiomyopathy with Left Ventricular Ejection Fraction (LVEF) ≤35%",[27],"2024-02-26",{"date":169,"type":38},"2024-02-28",{"date":171,"type":38},"2023-09-06",{"date":173,"type":21},"2027-10-01",{"name":175,"class":176},"Consorcio Centro de Investigación Biomédica en Red (CIBER)","OTHER_GOV",31]