[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myocardial-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myocardial-fibrosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,50,78,101,131,153,184,212,235],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100566461","phase-2-triple-combination-therapy-arni-sglt2i-mra-in-advanced-hfpef-100566461",false,"NCT06655480","Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF","Effect on Clinical Status, Structural and Functional Cardiac Parameters and Myocardial Fibrosis of Triple Combination Therapy With a Sodium-glucose Cotransporter 2 Inhibitor, Angiotensin Receptor\u002FNeprilysin Inhibitor and Mineralocorticoid Receptor Antagonist in Patients With Advanced HFpEF","Inclusion Criteria:\n\n1. Signed and data informed consent;\n2. Symptoms and signs of HF;\n3. LV ejection fraction \\> 50%;\n4. NT-proBNP \\> 300 pg\u002FmL (for patients with atrial fibrillation NT-proBNP \\> 900 pg\u002FmL)\n5. LV diastolic dysfunction II-III grade OR\n\nLV diastolic dysfunction I grade and at least 2 out of 4:\n\n* Е\u002Fе' \\> 14\n* LAVi \\> 34 ml\u002Fm2 (for those with persistent atrial fibrillation \\> 40 ml\u002Fm2)\n* PASP \\> 35 mm Hg or TR velocity \\> 2.8 m\u002Fsec\n* LV mass index \\> 95 g\u002Fm2 for women \u002F \\> 115 g\u002Fm2 for men or LV interventricular septum or posterior wall thickness ≥ 1.1 sm OR\n\nChronic atrial fibrillation and at least 3 out of 4:\n\n* Е\u002Fе' \\> 11\n* E-wave velocity \\> 100 sm\u002Fs\n* TR velocity \\> 2.8 sm\u002Fs\n* DT ≤ 160 ms\n\nExclusion Criteria:\n\n1. Evidence of myocardial ischemia during stress echocardiography;\n2. Significant lesions of main coronary arteries;\n3. Atrial fibrillation with resting HR \\> 110 beats\u002Fmin;\n4. Continuous (\\>90 days) treatment with ARNI, SGLTi and\u002For AMR within 12 months prior to screening. The last administration of these drugs must be at least 30 days prior to randomization. Treatment with these drugs should not be interrupted for the purpose of inclusion in the study.\n5. Coronary bypass surgery, stroke or TIA within the last 3 months of screening;\n6. Myocardial infarction or myocardial revascularization within the last 3 months of screening;\n7. Systolic blood pressure \\\u003C 90 mmHg or ≥ 180 mmHg at screening or randomization;\n8. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);\n9. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;\n10. Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases;\n11. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);\n12. Primary pulmonary artery hypertension;\n13. Significant left sided structural valve disease;\n14. Anemia (Hb \\\u003C 100 g\u002FL);\n15. Obesity (body mass index \\> 50 kg\u002Fm2);\n16. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI);\n17. Impaired liver function (serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 × upper limit of normal);\n18. Addison's disease;\n19. Known hypersensitivity to medications used the in the study;\n20. Non-cardiac conditions that complicate\u002Fexclude participation in the study;\n21. Diseases associated with isolated LV insufficiency (idiopathic pulmonary hypertension, chronic thromboembolic pulmonary hypertension, etc.);\n22. Serum\u002Fplasma potassium \\>5.0 mmol\u002FL at screening or randomization or a history of hyperkalemia or acute renal failure during AMR treatment for \\>7 consecutive days leading to discontinuation of AMR treatment.\n23. For patients with diabetes mellitus:\n\n    * Type 1 diabetes mellitus;\n    * Presence of more than 4 episodes of moderate hypoglycemia within the past month or at least one episode of severe hypoglycemia within the past year;\n    * Glycated hemoglobin level \\> 9% or \\\u003C6%","ALL","40 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Patients with advanced heart failure with preserved ejection fraction (HFpEF) will be randomly assigned in open-label multicenter study to receive triple combination therapy with \\[angiotensin receptor\u002Fneprilysin inhibitor \\[ARNI\\] + sodium-glucose cotransporter 2 inhibitor \\[SGLTi\\] + mineralocorticoid receptor antagonist \\[MRA\\]) or with individualized medical therapy \\[SGLTi + renin-angiotensin system inhibitor \\[RASi\\] \\[angiotensin receptor blocker \\[ARB\\] or angiotensin-converting enzyme inhibitor \\[ACE-I\\]), and will be treated for 52 weeks",[27,28,29],"HFpEF","LVDD","Myocardial Fibrosis",[27,31,32,33,34,35,36],"HF","left ventricular hypertrophy","diastolic dysfunction","cardiac reserves","LV filling pressures","myocardial fibrosis","RECRUITING","2026-04-21",{"date":40,"type":41},"2026-04-24","ACTUAL",{"date":43,"type":41},"2025-03-18",{"date":45,"type":21},"2027-12-31",{"name":47,"class":48},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","OTHER_GOV",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100633736","a-health-coach-led-digital-lifestyle-intervention-healdi-100633736","NCT07530562","A Health Coach-Led Digital Lifestyle Intervention (HEALDI)","A Health Coach-Led Digital Lifestyle Intervention (HEALDI) for the Regression of Diffuse Myocardial Fibrosis: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Left ventricular hypertrophy on cardiovascular magnetic resonance based on local age and sex specific criteria\n* Age 40-70 years old\n* Has internet access\n* Owns and uses a smartphone daily\n* Able to converse and comprehend the English or Chinese language\n\nExclusion Criteria:\n\n* History of major cardiovascular events (MACE), which is defined as coronary heart disease death, non-fatal myocardial infarction, stroke\n* Diagnosed with secondary causes of hypertension (E.g., renal causes - renal artery stenosis, chronic renal failure; endocrine causes- pheochromocytoma, Cushing's syndrome, hyperthyroidism; cardiac causes - coarctation of the aorta)\n* Diagnosed with significant coronary artery disease with previous percutaneous intervention or coronary artery bypass surgeries\n* Diagnosed with cardiac arrhythmias such as atrial fibrillation and frequent premature ventricular contractions\n* Diagnosed with inherited\u002Facquired cardiomyopathies (E.g., hypertrophic cardiomyopathy, dilated cardiomyopathy)\n* Diagnosed with infiltrative disease (E.g., cardiac amyloid, cardiac sarcoid)\n* Contraindications to Brain and Cardiac Magnetic Resonance or gadolinium contrast (E.g., renal failure- eGFR \\\u003C30ml\u002Fmin\u002Fm2 or documented contrast allergy; implantable devices such as cardiac pacemakers, brain aneurysms or clips, metal implants (including braces), foreign bodies in the eye; claustrophobia; end organ failure; women who are pregnant or breast-feeding)\n* Any pre-existing medical conditions or disabilities that limits their participation in lifestyle interventions (E.g., Dementia)\n* Individuals who have achieved the Singapore physical activity guideline of 150 minutes of moderate intensity exercise or 75 minutes of vigorous intensity exercise per week or an equivalent combination per week\n* Limited life expectancy of less than 12 months\n* Participating in other research projects involving behavioural therapy or changes related to physical activity","70 Years",{"count":59,"type":21},200,[61],"NA","Aim: To evaluate the effectiveness of an artificial intelligence (AI)-assisted 12-month Health Coach-Led Digital Lifestyle Intervention (HEALDI) versus control on diffuse myocardial fibrosis and ambulatory blood pressure in individuals with hypertensive heart disease (HHD), with secondary outcomes including multi-organ health parameters, health behaviours, social support, psychological health, and health-related quality of life.\n\nBackground: The global prevalence of hypertensive heart disease (HHD) has increased approximately 1.5-fold, from 7.82 million cases in 1990 to 12.50 million in 2021, and it is now the second leading cause of heart failure worldwide. In HHD, chronic pressure overload drives fibroblast activation and interstitial collagen deposition, leading to diffuse myocardial fibrosis which is associated with cardiac dysfunction, arrhythmias, impaired coronary flow reserve, and an increased risk of sudden cardiac death and heart failure. Although diffuse myocardial fibrosis is potentially reversible, no approved anti-fibrotic pharmacological therapy currently exists. Furthermore, there is limited evidence evaluating the effectiveness of lifestyle interventions, particularly aerobic exercise, in reversing diffuse myocardial fibrosis.\n\nDesign: A parallel, single-blinded two-arm randomised controlled trial.\n\nMethod: This study is a randomised controlled trial with repeated measures, recruiting 200 physically inactive individuals with HHD from the community, including participants from Project RESET, a community-based cohort study in Singapore. Participants will be randomly allocated to either the intervention or control group.\n\nParticipants in the intervention group will receive the 12-month HEALDI intervention, which includes the HEALDI mobile application, wearable device, and remote health coaching. Participants in the control group will receive a wearable device and a basic mobile application without intervention features, used solely for data collection.\n\nData will be collected at baseline (upon randomisation) and at 6, 12 and 24 months. A process evaluation will be conducted using intervention engagement data. In addition, semi-structured interviews with participants and health coaches will explore perceptions of the intervention and behaviour change. A within-trial economic evaluation, from both healthcare system and societal perspectives, will be performed to assess cost-effectiveness.\n\nSignificance: This study will generate insights into the role of lifestyle modification as a complementary, non-pharmacological strategy alongside pharmacotherapy to halt or slow HHD progression, improving long-term cardiovascular outcomes.",[29,64,65,66],"Left Ventricle Hypertrophy","Hypertensive Disease","Hypertension","NOT_YET_RECRUITING","2026-04-08",{"date":70,"type":41},"2026-04-15",{"date":72,"type":21},"2026-04",{"date":74,"type":21},"2028-06",{"name":76,"class":77},"National University of Singapore","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100512600","phase-4-high-relaxivity-contrast-agent-for-cardiac-mr-in-the-myocardial-scar-assessment-100512600","NCT05954559","High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment","Inclusion Criteria:\n\n* Participants from previous double-dose Doatrem CMR study who are willing to participate and sign the consent will be enrolled in this study. Participants must be ≥21 years old, less than 120kg, not claustrophobic, and eGFR be 60 and more.\n\nExclusion Criteria:\n\n* Participants under 21 years old will be excluded. Contraindications or limitations to contrast-enhanced MRI such as self-report of kidney disease, including kidney transplant or kidney surgery, eGFR less than 60, Metal fragments in eyes, brain, or spinal cord, Internal electrical devices such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator, pregnancy, allergic reaction to gadolinium in the past, claustrophobia, and cardiogenic shock or unstable condition that cannot tolerate the MRI scan will be excluded.",true,"21 Years",{"count":87,"type":21},25,[89],"PHASE4","Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated.\n\nThe hypothesis for the study: Half dose (0.05mmol\u002Fkg) Elucirem is not inferior to double dose (0.2 mmol\u002Fkg) Dotarem in the myocardial scar assessment.\n\nAll participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol\u002Fkg and five for 0.075 mmol\u002Fkg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.",[29],{"date":93,"type":41},"2026-04-13",{"date":95,"type":41},"2025-08-01",{"date":97,"type":21},"2026-12",{"name":99,"class":77},"Johns Hopkins University",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":49},"100462485","phase-1-phase-ia-and-ib-study-of-aavrh10hfxn-gene-therapy-for-the-cardiomyopathy-of-friedreichs-ataxia-100462485","NCT05302271","Phase IA and IB Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia","Inclusion Criteria:\n\n* Males and females, age 12 to 50\n* Willing and able to provide informed consent\n* Definitive diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on both alleles)\n* \\>600 GAA repeats in intron 1 in at least one allele\n* FARS and SARA neurologic scores consistent with diagnosis of Friedreich's ataxia\n* Left ventricle ejection fraction (EF) measured by cardiac MRI of ≥35% to 75%\n* Evidence of FA-related cardiac disease, must meet the following criteria: must be abnormal in ≥2 of the following parameters, at least one of which is an abnormal cardiac MRI left ventricular mass index or abnormal cardiopulmonary exercise test\n\n  1. Adults: In the absence of other factors known to cause left ventricular hypertrophy, cardiac MRI left ventricular mass index \\>2 standard deviations above the normal range (males \\>84 gm\u002Fm2, females \\>69 gm\u002Fm2 or Pediatrics: In the absence of other factors known to cause left ventricular hypertrophy, cardiac MRI left ventricular mass index \\>95th centile based on normal BSA for their age and gender\n  2. Cardiopulmonary arm crank testing with assessment of VO2 max ≤20 mL\u002Fkg-min, peak VO2 ≥10 mL\u002Fkg-min while maintaining revolutions of ≥40\u002Fmin. To insure consistency of effort, peak RER ≥1.0\n  3. Cardiac MRI stroke volume index \\\u003C45 mL\u002Fm2\n  4. Cardiac MRI global longitudinal left ventricular strain \\\u003C20%\n  5. Serum high-sensitivity cardiac troponin above the normal range\n* Fibrosis ≤10% in the left ventricular wall on late gadolinium enhancement cardiac MRI\n* Resting O2 saturation ≥95%\n* Serum neutralizing anti-AAVrh.10 titer \\\u003C1:125\n* Hematocrit \\>30%\n* White blood cell levels within normal limits\n* Normal prothrombin, partial thromboplastin time\n* Normal liver-related serum parameters (ALT, AST, ALP, bilirubin); normal liver ultrasound and serum alpha fetoprotein\n* Normal kidney function as assessed by plasma urea and creatinine; estimated GFR \\>30 mL\u002Fmin\u002F1.73m2\n* No evidence of active infection of any types, including hepatitis virus (A, B or C), human immunodeficiency virus (HIV-1 and HIV-2), or SARS-CoV2\n* Fertile individuals should utilize barrier birth control measures to prevent pregnancy for up to 6 months after vector administration\n* Individuals not receiving experimental medications or participating in another experimental protocol for at least 12 wk prior to entry to the study (individuals who are\u002Fhave received approved therapy will be included).\n* Capable of undergoing cardiac MRI\n* No contraindications to receiving corticosteroid immunosuppression\n\nExclusion Criteria:\n\n* Individuals receiving corticosteroids or other immunosuppressive medications\n* Individuals with uncontrolled diabetes (glycated hemoglobin, HbA1c levels \\>7%)\n* Genotype FA missense mutation on one or both alleles\n* Evidence of infection defined by elevated white blood cell count, temperature \\>38.5̊ C, infiltrate on chest x-ray\n* Decompensated heart failure (NY4A class III-IV at time of baseline clinical assessment)\n* Hemoglobin \\\u003C10 g\u002Fdl\n* Absolute neutrophil count \\\u003C1500 cells\u002Fmm3\n* Platelet count \\\u003C100,000 cells\u002Fmm3\n* Hemodynamically unstable atrial or ventricular arrhythmias which require medical intervention\n* Contraindication to cardiac MRI (e.g., non-MRI compatible pacemaker\u002Fdefibrillator) or gadolinium (known or suspected hypersensitivity, glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2)\n* Any malignancy during the last five years, except basal cell skin cancer\n* Unrelated clinical condition with life expectancy \\\u003C12 months (prohibiting follow-up)\n* Concomitant conditions (other than FA) known to produce left ventricular hypertrophy, including aortic stenosis, systemic hypertension (BP ≥140\u002F90 on noninvasive blood pressure), or genetically mediated hypertrophic cardiomyopathy\n* Use of oxygen supplementation\n* Risk for thromboembolic disease, including history of thromboembolic disease hospitalization within the last 90 days, recent trauma and\u002For recent surgical procedure. If the history of thromboembolic disease is not definitive, the subject will be excluded if laboratory testing suggests a risk for thromboembolic disease because of mutations in the protein-S, protein C, antithrombin, factor V Leiden or prothrombin gene\n* Any uncontrolled psychiatric disease\n* Pregnant or breastfeeding woman\n* Prior participation in any gene and\u002For cell therapy\n* Known obstructive coronary artery disease (as documented by clinical history of myocardial infarction, prior coronary revascularization or angina symptoms (Canadian Cardiovascular Society grade ≥2 at time of baseline clinical assessment), or epicardial obstructive coronary artery disease (≥ 50% left main, ≥ 70% of other major coronary arteries)\n* Any lung function abnormalities that would affect cardiopulmonary testing\n* Any condition, disorder, or abnormal laboratory test findings at screening which, in the judgment of the investigator, would interfere with the individual's ability to comply with all study requirements, or would require the administration of treatment during the study that could potentially affect the interpretation of the study data, or would place the individual at an unacceptable risk by his\u002Fher participation in the study\n* If prior infection with SARS-CoV2, any related residual cardiac or pulmonary abnormalities\n* Alcoholism or drug addiction (see reference 71 for alcoholism, reference 72 for drug addiction)","12 Years","50 Years",{"count":87,"type":21},[111],"PHASE1","The purpose of this study is to test the safety and preliminary efficacy of AAVrh.10hFXN to treat the cardiomyopathy associated with Friedreich's ataxia (FA). AAVrh.10hFXN is a serotype rh.10 adeno-associated virus gene transfer vector coding for Frataxin (FXN). The drug is administered intravenously. This is a phase 1, open label, dose escalation study with a total of 25 participants.",[114,115,116,29],"Friedreich Ataxia","Cardiomyopathies","Cardiac Hypertrophy",[118,119,120,121],"Ataxia","Friedreich's ataxia","Pediatric","Gene therapy","2026-03-30",{"date":124,"type":41},"2026-03-31",{"date":126,"type":41},"2022-02-22",{"date":128,"type":21},"2029-12-31",{"name":130,"class":77},"Weill Medical College of Cornell University",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100557299","phase-4-neprilysin-inhibition-to-reduce-myocardial-fibrosis-in-heart-failure-with-preserved-ejection-fraction-100557299","NCT06536309","Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n* Adults aged 50 years or older\n* Able to provide informed consent, as assessed by a physician investigator, and willing to comply with the study\n* Clinically confirmed diagnosis of heart failure\n* Left ventricular ejection fraction greater than or equal to 45% within 1 year by echocardiogram, cardiac MRI, or nuclear scan\n\nExclusion Criteria:\n\n* Contraindication to MRI (metal prosthesis, implantable cardiac device, or severe claustrophobia)\n* Systolic blood pressure \\\u003C 100mm Hg, or \\\u003C110 mm Hg for patients not taking an ACE inhibitor or angiotensin receptor blocker\n* symptomatic hypotension\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 within 60 days of enrollment\n* Serum potassium \\>5.2mmol\u002FL within 60 days of enrollment, or \\>5.0 mmol\u002FL for patients not taking an ACE inhibitor or angiotensin receptor blocker\n* Myocardial infarction within 6 months of enrollment\n* Infiltrative or hypertrophic cardiomyopathy\n* History of cirrhosis, biliary cirrhosis, or cholestasis\n* History of angioedema\n* Pregnancy, planning pregnancy, or breastfeeding\n* Active treatment with lithium or a direct renin inhibitor","85 Years",{"count":139,"type":21},36,[89],"Cardiac magnetic resonance imaging (MRI) measures of myocardial interstitial fibrosis (MIF) are elevated in heart failure with preserved ejection fraction (HFpEF) patients and associated with poor prognosis. Extracellular volume (ECV) is the most reproducible and best validated cardiac MRI measure of MIF. Sacubitril\u002Fvalsartan reduces histological MIF in mice and levels of some extracellular matrix regulatory proteins in humans with HFpEF. However, the effect of sacubitril\u002Fvalsartan on robust measures of MIF in humans is unknown. Demonstrating reductions in ECV with sacubitril\u002Fvalsartan would clarify the mechanism of this approved medication. Given the borderline reduction in heart failure hospitalizations with sacubitril\u002Fvalsartan and the heterogeneity of HFpEF pathophysiology, this result would suggest that neprilysin inhibition may particularly benefit HFpEF patients with greater MIF. The investigators propose a proof-of-concept clinical trial to evaluate the effect of neprilysin inhibition (sacubitril\u002Fvalsartan vs valsartan alone) on cardiac MRI measures of fibrosis (principally ECV) and circulating protein levels.",[143,29],"Heart Failure With Preserved Ejection Fraction","2026-02-24",{"date":146,"type":41},"2026-02-25",{"date":148,"type":21},"2026-07",{"date":150,"type":21},"2029-09",{"name":152,"class":77},"Brigham and Women's Hospital",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":84,"sex":16,"minAge":160,"maxAge":4,"enrollmentInfo":161,"targetDuration":163,"studyType":164,"phases":4,"briefSummary":165,"conditions":166,"keywords":171,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":49},"100396593","improving-cardiovascular-risk-stratification-using-t1-mapping-in-general-population-100396593","NCT04444128","IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION","IMPReSSION","Inclusion Criteria:\n\n1. Able to provide informed consent\n2. 18 years of age and over\n3. Absence of a valid clinical indication for CMR, and\u002For known or clinically relevant cardiac disease\n\nExclusion Criteria:\n\n* accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)","18 Years",{"count":162,"type":21},6000,"5 Years","OBSERVATIONAL","Magnetic properties of myocardial tissue change in the presence of disease. This is detectable in the change of rate of magnetic relaxation, and measurable by T1 and T2 mapping using cardiovascular magnetic resonance (CMR). These markers provide novel quantifiable imaging measures for myocardial tissue characterisation. Despite similar principles, the measurements differ considerably between different sequences, vendors and field strengths, yielding a necessity to establish robust sequence-specific normal ranges, diagnostic accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine cardiac imaging parameters, and prognosis. A further unknown relates to separation between healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac involvement. Examples include patients with possible inflammation, such as in patients with a recent COVID-19 infection or vaccination. Anticipated recruitment of a total of 3000 subjects, with 1500 subjects per field strength (1.5 and 3.0 Tesla).",[167,168,29,169,170],"Myocarditis","Heart Failure","Vascular Inflammation","Long COVID Syndrome",[172,173,174],"Inflammation","Remodeling","vascular inflammation","2026-01-02",{"date":177,"type":41},"2026-01-06",{"date":179,"type":41},"2016-11-15",{"date":181,"type":21},"2030-06-30",{"name":183,"class":77},"Johann Wolfgang Goethe University Hospital",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":160,"maxAge":4,"enrollmentInfo":192,"targetDuration":194,"studyType":164,"phases":4,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":49},"100615705","ga-fapi-petct-for-cardiac-fibrosis-in-heart-failure-100615705","NCT07296081","⁶⁸Ga-FAPI PET\u002FCT for Cardiac Fibrosis in Heart Failure","Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET\u002FCT","MY-FAPI","Inclusion Criteria:\n\n* ≥ 18 years old;\n* Signs and symptoms of heart failure (HF);\n* \\[Preserved left ventricular ejection fraction (LVEF) (≥50%) and Evidence of structural\u002Ffunctional abnormality consistent with diastolic dysfunction\u002Fincreased ventricular filling pressures, including elevated natriuretic peptides and Imaging diagnosis of hypertrophic cardiomyopathy and Genetic diagnosis of hypertrophic cardiomyopathy due to sarcomeric gene mutation\\] OR \\[Reduced LVEF (≤40%) and Imaging diagnosis of dilated cardiomyopathy: left ventricular end-diastolic diameter \\>58 mm in men and \\>52 mm in women, and left ventricular volume ≥75 mL\u002Fm² in men and ≥62 mL\u002Fm² in women, not explained solely by loading conditions\\]\n* Recent transthoracic echocardiogram (\\\u003C 3 months);\n* Recent cardiac magnetic resonance imaging (\\\u003C 3 months).\n* Normal coronary angiogram or computed tomography coronary angiography within 6 months of enrolment\n\nExclusion Criteria:\n\n* Inability to provide informed consent;\n* Inability to tolerate the supine position;\n* Hemodynamic instability;\n* Claustrophobia;\n* Chronic kidney disease with glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m²;\n* Pregnant or breastfeeding women;\n* Malignant neoplasms within the past 5 years;\n* Significant primary valvular disease;\n* Significant atherosclerotic coronary artery disease;\n* Grade 2 or 3 arterial hypertension;\n* Presence of an implanted cardiac electrical device;\n* Recent hospitalization for heart failure (\\\u003C30 days).",{"count":193,"type":21},30,"2 Years","Heart failure (HF) is a clinical syndrome with increasing incidence and prevalence, associated with high morbidity, mortality, and economic impact, despite therapeutic advances.\n\nMyocardial fibrosis is a common feature across different pathophysiological processes and plays a key role in HF development, with growing research interest specifically in non-ischemic dilated cardiomyopathy (HFrEF phenotype) and hypertrophic cardiomyopathy (HFpEF phenotype). Given its potential reversibility with certain drugs, fibrosis is an attractive therapeutic target, requiring non-invasive methods to monitor fibrogenesis and treatment efficacy.\n\nCardiac magnetic resonance imaging (CMR) is the gold standard for detecting fibrosis but cannot distinguish between active and inactive fibrosis or detect early stages, limitations that may be addressed by gallium-68-labeled fibroblast activation protein inhibitor positron emission tomography\u002Fcomputed tomography (68Ga-FAPI PET\u002FCT).\n\nThis single-center, prospective, observational pilot study aims primarily to assess myocardial fibrosis in patients with HFrEF (non-ischemic dilated cardiomyopathy) and a subtype of HFpEF (hypertrophic cardiomyopathy) using 68Ga-FAPI PET\u002FCT compared to CMR.\n\nSecondary objectives include developing 68Ga-FAPI uptake assessment methodologies for future anti-fibrotic therapy studies and correlating fibrosis with serum cardiac biomarkers and cardiovascular events.",[29,168],[198,199,200,201,202],"Fibroblast activation protein inhibitors","Gallium-68","Heart failure","Myocardial fibrosis","Positron emission tomography","2025-12-21",{"date":205,"type":41},"2025-12-29",{"date":207,"type":41},"2025-11-17",{"date":209,"type":21},"2028-12-31",{"name":211,"class":77},"University of Coimbra",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":160,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":49},"100592499","fibrosis-assessment-in-myocardial-infarction-associated-ventricular-aneurysm-100592499","NCT06994221","Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm","Assessment of Myocardial Fibrosis by 18F-FAPI\u002FPET-CT in Patients With Myocardial Infarction-associated Ventricular Aneurysm","Inclusion Criteria:\n\n* Aged 18-75 years old\n* Diagnosed with STEMI or NSTEMI (ACC\u002FAHA guidelines)\n* Half male and half female\n* Undergo CAG and PCI treatment;\n* Receive either echocardiography or CMR to identify a ventricular aneurysm;\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients under the age of 18 years old;\n* Patients who are pregnant\u002Fbreastfeeding;\n* Patients who has a previous history of allergy to radio tracers.","75 Years",{"count":221,"type":21},20,"The study will use 18F-FAPI PET\u002FCT to study myocardial fibrosis in patients diagnosed with myocardial infarction-associated ventricular aneurysm (MI-VA). Participants will receive the PET\u002FCT scan during hospital stay, as well as serial echocardiography and telephonic follow-ups. Analysed will focus on the characterization of myocardial fibrosis and its correlations with the clinical prognosis in the patients.",[224,225,29],"Acute Myocardial Infarction","Ventricular Aneurysm Following Acute Myocardial Infarction","2025-05-20",{"date":228,"type":41},"2025-05-29",{"date":230,"type":41},"2024-11-01",{"date":232,"type":21},"2025-12-31",{"name":234,"class":77},"RenJi Hospital",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":84,"sex":16,"minAge":85,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":49},"100260482","response-of-the-myocardium-to-hypertrophic-conditions-in-the-adult-population-100260482","NCT02670031","Response of the Myocardium to Hypertrophic Conditions in the Adult Population","Inclusion Criteria:\n\n1. 21 years and over\n2. Physician diagnosed essential hypertension, on at least 1 medication for blood pressure control\n3. Newly diagnosed hypertension: systolic blood pressure 140mmHg or greater (diastolic blood pressure 90mmHg or greater) on at least 2 office visits (Weber 2013) and not started on any anti hypertensive medications at time of ambulatory blood pressure monitoring\n4. Resistant hypertension: persistent systolic blood pressure 140mmHg or greater (diastolic blood pressure 90mmHg or greater) despite on at least 3 anti-hypertensive medications (Jennings 2013; Weber 2013)\n\nExclusion Criteria:\n\n1. Known secondary hypertension: renal causes (renal artery stenosis, chronic renal failure); endocrine causes (aldosterone excess, pheochromocytoma, cushing's syndrome, hyperthyroidism); cardiac causes (coarctation of the aorta)\n2. Contraindications to cardiovascular magnetic resonance: implantable devices, cerebral aneurysm clips, cochlear implants, renal impairment (GRF \\\u003C30ml\u002Fmin\u002F1.73m2), claustrophobia and women who are pregnant or breast-feeding\n3. Limited life expectancy\n4. On-going unstable medical conditions: hypertensive crisis, acute coronary syndromes or acute heart failure\n5. History of coronary artery disease, ischemic heart disease\n6. History of transient ischemic attacks or cerebrovascular events\n7. History of atrial fibrillation\n8. History of heart failure","99 Years",{"count":243,"type":21},2000,"Hypertension and aortic stenosis are the two leading conditions that cause thickening of the heart muscles (left ventricular hypertrophy). Left ventricular hypertrophy is initially adaptive to maintain optimal heart function. Ultimately, heart failure occurs as a result of progressive muscle cell death and scarring (myocardial fibrosis). Dedicated techniques using cardiovascular magnetic resonance imaging (MRI) and novel high-sensitivity cardiac troponin blood assays are potential markers to detect myocardial fibrosis. Although hypertension-related heart disease is very common in Singapore, the significance of myocardial fibrosis is not well understood. In this study, the significance of myocardial fibrosis in 2000 patients with hypertension would be investigated. This will be the largest study using state-of-the-art MRI to examine the importance of myocardial fibrosis in hypertensive heart disease. 1000 participants, with at least 1 year follow-up, will be invited for a repeat assessment.",[246,66,29],"Left Ventricular Hypertrophy",[248,66,246,29,249],"Hypertensive Heart Disease","Cardiovascular Magnetic Resonance Imaging","2023-07-31",{"date":252,"type":41},"2023-08-02",{"date":254,"type":4},"2016-01",{"date":256,"type":21},"2031-09",{"name":258,"class":77},"National Heart Centre Singapore"]