[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hfmref\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hfmref":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100604253","phase-4-clinical-trial-to-evaluate-the-efficacy-and-safety-in-concomitant-administration-of-macitentan-and-dapagliflozin-in-patients-with-heart-failure-with-mildly-reduced-and-preserved-ejection-fraction-hfmref-and-hfpef-and-combined-pre--and-post-capillary-pulmonary-hypertension-cpcph-100604253",false,"NCT07147114","Clinical Trial to Evaluate the Efficacy and Safety in Concomitant Administration of Macitentan and Dapagliflozin in Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction (HFmrEF and HFpEF) and Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH)","A Multicenter, Randomized, Double-Blind, Exploratory Clinical Trial to Evaluate the Efficacy and Safety in Concomitant Administration of Macitentan and Dapagliflozin in Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction (HFmrEF and HFpEF) and Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH)","Inclusion Criteria:\n\n\\\u003CScreening Visit (Visit 1)\\>\n\n1. A male or female adults aged 19 years or older in South Korea\n2. LVEF greater than 40% on echocardiogram performed within 12 weeks prior to screening\n3. Presence of heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) accompanied by combined pre- and post-capillary pulmonary hypertension (CpcPH)\n4. Meeting all of the following criteria on RHC performed within 48 weeks prior to screening:\n\n   1. mPAP \\> 20 mmHg\n   2. PVR \\> 2 Wood units (WU)\n   3. PAWP \\> 15 mmHg\n5. World Health Organization Functional Class (WHO-FC) II or III at the time of screening\n6. If taking any of the following medications at the time of screening, the participant must have been on a stable dose for at least 3 months:\n\n   1. Renin-angiotensin system inhibitors\n   2. Beta-blockers\n   3. Mineralocorticoid receptor antagonists (aldosterone antagonists)\n   4. Sodium-glucose cotransporter-2 (SGLT2) inhibitors\n   5. Ivabradine\n\n\\\u003CBaseline Visit (Visit 2)\\>\n\n1\\. World Health Organization Functional Class (WHO-FC) II or III at the time of baseline visit\n\nExclusion Criteria:\n\n\\\u003CScreening Visit (Visit 1)\\>\n\n1. Known hypersensitivity to the active ingredients (Macitentan, Dapagliflozin) or any excipients of the investigational medicinal product\n2. Pregnant or breastfeeding women, or those who do not agree to use at least two appropriate contraceptive methods\\* (self or partner) during the clinical trial period and for 30 days after the last administration of the investigational medicinal product (for male participants, those who do not agree to refrain from sperm donation)\n\n   \\*: a. Surgical sterilization (e.g., vasectomy) or intrauterine device (IUD; copper IUD or hormone-releasing intrauterine system), b. Non-oral hormonal contraceptive or spermicide in combination with a barrier method, c. Cervical cap or diaphragm used in combination with a male condom.\n3. Participants with type 1 diabetes mellitus or secondary diabetes mellitus\n4. Participants with metabolic acidosis, such as diabetic ketoacidosis\n5. Participants diagnosed with pulmonary hypertension other than WHO Group 2 pulmonary hypertension (i.e., WHO Group 1, 3, 4, or 5)\n\n   1. Group 1: Pulmonary arterial hypertension\n   2. Group 3: Pulmonary hypertension associated with lung diseases and\u002For hypoxia\n   3. Group 4: Chronic thrombo-embolic pulmonary hypertension\n   4. Group 5: Pulmonary hypertension with unclear and\u002For multifactorial mechanisms\n6. Participants who meet the following criteria on RHC performed within 12 weeks prior to screening:\n\n   a. PAWP ≤ 15 mmHg\n7. History of taking any of the following medications within 4 weeks prior to screening:\n\n   1. Calcium channel blockers\n   2. Endothelin receptor antagonists\n   3. Phosphodiesterase type 5 inhibitors (PDE5i)\n   4. Riociguat\n   5. Prostacyclin (PC) analogs or prostacyclin receptor agonists\n   6. Activin signaling inhibitors\n8. History of any of the following medical conditions, surgeries, or procedures:\n\n   1. Myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention (PCI) within 3 months prior to screening\n   2. Uncontrolled tachycardia (\\>110 bpm) due to atrial fibrillation or atrial flutter\n   3. History of heart transplantation or implantation of a ventricular assist device, or planned to undergo such procedures\n9. eGFR ≤ 30 mL\u002Fmin\u002F1.73 m² or AST or ALT ≥ 2.5 × ULN\n10. Urinary tract infection, genital infection (including fungal infections), or voiding disorder within 24 weeks prior to screening\n11. Hemoglobin \\\u003C 9 g\u002FdL at the time of screening\n12. Participants with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n13. Known hypersensitivity to soybean oil or history of soybean oil allergy\n14. Known hypersensitivity to soy or peanuts\n15. Participation in another clinical trial involving administration\u002Fapplication of an investigational medicinal product or medical device within 3 months prior to screening\n\n\\\u003CBaseline Visit (Visit 2)\\>\n\n1. Participants who, upon re-confirmation of inclusion\u002Fexclusion criteria at the baseline visit, have any disqualifying condition\n2. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical trial","ALL","19 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This clinical trial will evaluate whether combination therapy with Dapagliflozin + Macitentan improves outcomes compared to Dapagliflozin + placebo in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH).\n\nThe study will measure changes in pulmonary vascular resistance, NT-proBNP, 6-minute walk distance, and quality of life (KCCQ scores) over 24 weeks.\n\nParticipants will be randomly assigned to one of two groups, take study medication for 24 weeks, and undergo regular clinical, laboratory, and safety assessments.",[26,27,28,29,30],"Combined Pre- and Post-capillary Pulmonary Hypertension","CpcPH","HFmrEF","HFpEF","Group 2 Pulmonary Hypertension","RECRUITING","2026-03-30",{"date":34,"type":35},"2026-04-03","ACTUAL",{"date":37,"type":35},"2025-11-24",{"date":39,"type":20},"2027-09-30",{"name":41,"class":42},"Gachon University Gil Medical Center","OTHER",15,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100609525","us-benchmarking-clinical-study-100609525","NCT07215715","US Benchmarking Clinical Study","Myocardial & Hepatic Shear Wave Velocity Measurements in Patients With Non-Reduced-Ejection Fraction Heart Failure and Control Subjects - US Benchmarking Clinical Study","EMS-CT-1","Inclusion Criteria:\n\nInclusion Criteria Common to all three Study Arms:\n\n1. Male or female age ≥ 60 years\n2. Signed informed consent and able to comply with protocol\n\n   Inclusion Criteria Common to the Heart Failure with non-reduced left ventricular ejection fraction (LVEF) with or without transthyretin amyloid cardiomyopathy (ATTR-CM) Arms:\n3. Patients meeting the Universal Definition of Heart Failure \\& HeartShare study criteria.\n4. LVEF \\>40% on the last available imaging study\n5. Left ventricular hypertrophy (LVH) defined as left ventricular mass index (mass\u002FBSA) in female \\> 95 g\u002Fm², in male \\> 115 g\u002Fm² according to American Society of Echocardiography\u002FEuropean Association of Cariology (ASE\u002FEAC) guidelines42 OR as interventricular septum (IVS) thickness ≥12 mm\n\n   Inclusion criterion specific to HF with non-reduced LVEF without ATTR-CM Arm:\n6. Negative (grade 0) Pyrophosphate (PYP) scintigraphy within 24 months prior to the enrolment in the study OR Simple Score \\\u003C643 OR negative endomyocardial biopsy\n\n   Inclusion criterion specific to HF with non-reduced LVEF with ATTR-CM Arm:\n7. ATTR-CM objectively confirmed and classified at any time prior to the enrollment in the study, with monoclonal protein AL amyloidosis ruled out, according to American Heart Association (AHA) 2020 criteria\n\n   Inclusion criteria in Control Subjects:\n8. No diagnosis of HF or cardiomyopathy according to the universal definition of Heart Failure\n9. No diagnosis of Transthyretin amyloid cardiomyopathy (ATTR-CM) or Amyloid light-chain (AL) amyloidosis\n\nExclusion Criteria:\n\nExclusion criteria common to the three arms:\n\n1. Pregnant OR pre-menopausal woman\n2. Vulnerable patients\n3. Acute Coronary Syndrome within 30 days\n4. Heart rate greater than 130 beats\u002Fminute at the time of the measurements\n5. Atrial fibrillation or flutter at the time of SWV measurement (history of AF is authorized provided they patient is in sinus rhythm at the time of the measurements)\n6. Any clinically significant cardiac arrhythmia at the time of SWV measurement\n7. Poor echogenicity preventing accurate ultrasound measurements\n8. Patients with segmental wall motion abnormalities thought to be due to myocardial infarction.\n9. Severe mitral or aortic valve disease (regurgitation or stenosis) excluded if the cause is other than ATTR (e.g., prolapse, endocarditis, prosthetic valve.)\n10. Severe tricuspid valve disease (regurgitation or stenosis) excluded if the causes are other than ATTR.\n11. Distance from skin to IVS ≥ 8 cm\n12. Any prosthetic mechanical valve\n13. Patients with mechanical cardiac assist devices other than pacemakers or defibrillators\n14. Heart, lung, liver or kidney transplant history or expected in the next year\n15. Severe renal impairment with eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m² or end-stage renal disease or patient on dialysis.\n16. Presence of any competing life-threatening risk over the next 12 months\n17. Complicated uncontrolled diabetes mellitus HbA1c ≥9% with target organ damage.\n18. Uncontrolled and persistent high-blood pressure with diastolic pressure \\> 100 mmHg or systolic pressure \\> 160 mmHg at the time of the measurement.\n19. Acute decompensated state such as volume overload, etc. in the opinion of the study investigator\n20. Skin abnormalities, infections, or open wounds at the site of the SVW measurement\n21. Liver disease, at least moderate\n\n    Exclusion criteria in both the HF with non-reduced LVEF with or without ATTR-CM Arms:\n22. Known inherited cardiomyopathy, infiltrative cardiomyopathy (other than ATTR-CM for the study arm for ATTR-CM), cardiomyopathy from muscular dystrophies, cardiomyopathy with reversible causes (e.g., stress cardiomyopathy), hypertrophic cardiomyopathy or known pericardial constriction\n23. History of treatment for ATTR-CM with Transthyretin (TTR) depleters\n\n    Exclusion criteria Specific to Control Subjects:\n24. Any diagnosis of cardiomyopathy or HF, whatever the cause46\n25. LVH based on LV mass index female \\>95 g\u002Fm², in male ≥115 g\u002Fm² OR IVS thickness ≥12 mm unless thought to be due to athlete's heart",true,"60 Years",{"count":55,"type":20},150,"OBSERVATIONAL","The goal of this observational study is to measure shear wave velocity (SWV) in patients with non-reduced left ventricular ejection fraction (LVEF) heart failure and left ventricular hypertrophy, with or without transthyretin amyloidosis with cardiomyopathy (ATTR-CM), and in control subjects without heart failure or cardiomyopathy.\n\nThe main question it aims to answer is:\n\n• Can SWV be used to measure myocardial and liver stiffness in the study's target populations? Researchers will compare patients with ATTR-CM, patients without ATTR-CM, and a control group to determine the distributions of SWV in each population.\n\nParticipants will:\n\n* Have a standard cardiology assessment, including a physical exam, blood work, and an echocardiogram.\n* Undergo an investigational assessment with the eMyosound LYRA device to measure SWV in their myocardium and liver.\n* Have the investigational assessment repeated by a second observer to assess measurement reliability.",[59,28,60,61,62],"HFpEF - Heart Failure With Preserved Ejection Fraction","ATTR-CM (Transthyretin Amyloid Cardiomyopathy)","Left Ventricular Hypertrophy","Cardiac Amyloidosis",[64,65,48,66,62,67],"Shear Wave Velocity","non-invasive ultrasound elastography","Heart Failure","ATTR-CM","2025-10-16",{"date":70,"type":35},"2025-10-20",{"date":72,"type":35},"2025-09-16",{"date":74,"type":20},"2026-07",{"name":76,"class":77},"eMyosound SAS","INDUSTRY",3]