Hypertrophic cardiomyopathy
Conditions
Interventions
Experimental group:For subjects with EGFR 60ml/min/1.73m^2 at baseline, the initial dose of fenneridone was 20mg per day. From visit 2 (the first month), if serum potassium <= 5.0mmol/l and EGFR decr
Placebo group:Administer placebo at the same dose as the experimental group.
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 80 years inclusive; 2. Diagnosed with hypertrophic cardiomyopathy (HCM) and meeting all of the following criteria: (1). Left ventricular wall thickness >=15 mm at any site during diastole; or >=13 mm in patients with positive pathogenic gene testing or genetically affected family members; (2).Left ventricular ejection fraction (LVEF) >40% within 2 weeks prior to randomization; (3).N-terminal pro-B-type natriuretic peptide (NT-proBNP) >125 pg/mL (without atrial fibrillation); NT-proBNP >300 pg/mL (with atrial fibrillation); (4).Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <80 points at screening; 6-minute walk distance (6MWD) <400 meters; (5).Have received guideline-recommended pharmacotherapy for HCM with stable doses for at least 4 weeks prior to randomization; 3.Have voluntarily provided written informed consent.
Exclusion criteria
Exclusion criteria: Patients will be excluded if any of the following criteria are met: 1.Other cardiovascular diseases, systemic or metabolic diseases that cause ventricular wall thickening; 2.Uncontrolled hypertension, defined as resting systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg on two separate assessments prior to randomization; 3.Estimated glomerular filtration rate (eGFR) 5.5 mmol/L; 8.Regular use of spironolactone within 1 week prior to randomization; 9.History of syncope within 3 months; stroke within 3 months; 10.Symptomatic bradycardia or second- or third-degree atrioventricular block without pacemaker implantation; 11.Malignant ventricular arrhythmias affecting hemodynamics; 12.Implantation of cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) within 6 months; upgrade of existing conventional pacemaker or implantable cardioverter-defibrillator (ICD) to CRT device within 6 months; or intention to implant such devices within 6 months; 13.Major cardiovascular or other major surgery within 3 months; percutaneous coronary intervention (PCI) or valvular interventional procedures within 1 month; planned revascularization (including percutaneous intervention or CABG), valvular intervention, septal myocardial ablation, modified extended Morrow procedure or other major surgery within the next 6 months; 14.History of heart transplantation or left ventricular assist device (LVAD) implantation; patients awaiting heart transplantation or with intention to use an LVAD; 15.Severe chronic obstructive pulmonary disease, cor pulmonale, severe pulmonary vascular disease, pulmonary hypertension secondary to autoimmune diseases, and severe pulmonary hypertension of any etiology; 16.History of major organ transplantation (e.g., lung, liver, heart, bone marrow, kidney); 17.Patients with severe primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrine system, malignancies, or psychiatric disorders; 18.Life expectancy less than 1 year; 19.Known hypersensitivity to any study drug; 20.Participation in another clinical drug trial within 1 month; 21.Pregnancy (positive pregnancy test) or breastfeeding; women of child-bearing potential without adequate contraception; 22.Patients deemed unable to complete the study or comply with study requirements by the investigator (for administrative or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 180-day change from baseline in KCCQ-CSS score;180-day change from baseline in 6-minute walk distance (6MWD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hierarchical composite endpoint;Cardiovascular death and HF rehospitalizations;All-cause death and HF rehospitalizations;Cardiovascular death; All-cause death;HF rehospitalizations; All-cause death or first HF rehospitalization;Cardiovascular death, HF rehospitalizations and worsening HF;All-cause death, HF rehospitalizations and worsening HF;Extracellular volume (ECV) assessed by cardiac magnetic resonance (CMR) at Day 90 and Day 180;90-day change from baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS);90-day change from baseline in 6-minute walk distance (6MWD);Proportion of patients with >30% reduction in NT-proBNP from baseline at Day 90 and Day 180;Change from baseline in NT-proBNP at Day 90 and Day 180;Change from baseline in troponin I (TnI) at Day 90 and Day 180;Change from baseline in peak oxygen consumption (pVO?) at Day 90 and Day 180;Change from baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score at Day 90 and Day 180;Change from baseline in EQ-5D-5L scores (health utility index, visual analogue scale (VAS)) at Day 90 and Day 180;New York Heart Association (NYHA) functional class at Day 90 and Day 180;Exploratory Endpoint: Change from baseline in soluble suppression of tumorigenicity 2 (sST2) at Day 90 and Day 180; | — |
Countries
China
Contacts
Public ContactYuhui Zhang
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed