Hypertrophic cardiomyopathy
Conditions
Interventions
Experimental group:Administer vericiguat. The recommended starting dose is 5 mg/day. During the treatment period, dose titration should be performed at each follow-up visit based on blood pressure, sy
- If SBP <90 mmHg, temporarily withhold dose escalation and continue the current dose.
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. Age >= 18 years old and = 15 mm. For with those positive pathogenic gene testing or members of genetically affected families, the left ventricular wall thickness >= 13 mm; (2). Left ventricular ejection fraction (LVEF) is not restricted; (3). NT - proBNP > 125 pg/ml (without atrial fibrillation); NT - proBNP > 300 pg/ml (with atrial fibrillation); (4). During the screening period, the Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ - CSS) < 80 points; 6 - minute walk distance (6MWD) < 400 meters; (5).Have previously received drug treatment for hypertrophic cardiomyopathy recommended by the guidelines, and the dosage has been stable for more than 4 weeks. 3. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Other cardiovascular diseases or systemic and metabolic diseases that cause thickening of the ventricular wall; 2.Poorly controlled hypertension, defined as resting systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg on two separate occasions before randomization; 3.Systolic blood pressure <90 mmHg and/or symptomatic hypotension; 4.Glomerular filtration rate <25 ml/min/1.73m^2; 5.Valvular heart disease or congenital heart disease without surgical intervention; 6.Cardiogenic shock; active myocarditis; constrictive pericarditis and other pericardial diseases; 7.History of syncope within 3 months; stroke within 3 months; 8.Symptomatic bradycardia or second- or third-degree heart block without a pacemaker; 9.Malignant ventricular arrhythmias affecting hemodynamics; 10.Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) within 6 months, or upgrade of an existing conventional pacemaker or implantable cardioverter-defibrillator (ICD) to a CRT device, or intention to implant a similar device within 6 months; 11.Major cardiovascular surgery or other major surgery within 3 months; percutaneous coronary intervention (PCI) or valvular or other interventional procedures within 1 month; planned revascularization (including percutaneous intervention or CABG), valvular, ventricular septal myectomy ablation, or other interventional procedures such as modified Morrow procedure or other major surgery within the next 6 months; 12.History of heart transplantation or LVAD, or currently awaiting transplantation or intention to use a left ventricular assist device (LVAD); 13.Severe chronic obstructive pulmonary disease, cor pulmonale, severe pulmonary vascular disease, pulmonary arterial hypertension caused by autoimmune diseases, and any type of severe pulmonary hypertension; 14.History of major organ transplantation (e.g., lung, liver, heart, bone marrow, kidney); 15.Concurrent severe primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrine system, etc., tumor patients, and patients with mental disorders; 16.Life expectancy less than 1 year; 17.Known allergy to any investigational drug; 18.Participation in other clinical drug studies within 1 month; 19.Pregnancy (positive pregnancy test) or breastfeeding; women of childbearing age not using adequate contraceptive measures; 20.Inability to complete the study or comply with study requirements (due to administrative reasons or other reasons) as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of NT - proBNP with a decrease of >30% compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular death and rehospitalization for heart failure;Cardiovascular death or first heart failure rehospitalization;All-cause death and heart failure rehospitalization;Cardiovascular death;All-cause death;Heart failure rehospitalization;All-cause death or first heart failure rehospitalization;Cardiovascular death, rehospitalization for heart failure, and worsening heart failure;All-cause death, rehospitalization for heart failure, and worsening heart failure;CMR evaluation of extracellular volume;Change from baseline in KCCQ-CSS score;Change from baseline in 6-minute walk distance;Proportion of patients with >30% decrease in NT-proBNP from baseline;Change from baseline in NT-proBNP ;Change from baseline in TnI;Change from baseline in pVO2;Change from baseline in MLHFQ score;Change from baseline in EQ-5D-5L score (health utility value, VAS);NYHA functional class;Changes from baseline in left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), interventricular septal thickness (IVST), mitral diastolic flow velocity (E wave, A wave), and average E/e' ratio.; | — |
Countries
China
Contacts
Public ContactYuhui Zhang
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed