Effect of beta-blockers combined with angiotensin II receptor blockers in regression of cardiac hypertrophy in patients with hypertrophic cardiomyopathy: A multicenter randomized, controlled clinical trial

• Register: ChiCTR
• Last refreshed on: 15 October 2018
• Main ID: ChiCTR-IIR-17013661
• Date of registration: 2017-12-03
• Prospective Registration: Yes
• Primary sponsor: The First Affiliated Hospital, Sun Yat-sen University
• Public title: Effect of beta-blockers combined with angiotensin II receptor blockers in regression of cardiac hypertrophy in patients with hypertrophic cardiomyopathy: A multicenter randomized, controlled clinical trial
• Scientific title: Effect of beta-blockers combined with angiotensin II receptor blockers in regression of cardiac hypertrophy in patients with hypertrophic cardiomyopathy: A multicenter randomized, controlled clinical trial
• Date of first enrolment: 2018-10-10
• Target sample size: Experimental group:130;Control group:130;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=23290
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: IV (Phase IV study)

Countries of recruitment

China

Contacts

• Name: Zexuan Wu
• Affiliation: The First Affiliated Hospital, Sun Yat-sen University

• Name: Yugang Dong
• Affiliation: The First Affiliated Hospital, Sun Yat-sen University

Key inclusion & exclusion criteria

Inclusion criteria: Patients aged 18 to 65 years old will be eligible for inclusion if they had unexplained left ventricular hypertrophy with either a maximum wall thickness of 15 mm or more on echocardiography or borderline hypertrophy (maximum wall thickness 13-14 mm) on echocardiography and at least one first-degree relative with hypertrophic cardiomyopathy. Only patients with the left ventricular ejection fraction more than 50% will be eligible.
Exclusion criteria: Known hypersensitivity to losartan or metoprolol, current treatment with an ACE inhibitor or ARB, symptomatic hypotension and/or resting systolic blood pressure lower than 100 mmHg, symptomatic bradycardia and/or resting heart rate lower than 60 betas per min, or second or third degree heart block without a pacemaker, patients with asthma or chronic obstructive pulmonary disease that are expected to be intolerant to large doses of metoprolol succinate, known or suspected unilateral or bilateral renal artery stenosis, renal insufficiency with an estimated glomerular filtration rate of less than 30 mL/min per 1.73m^2, hyperkalemia, atrial fibrillation that affect image quality of cardiac magnetic resonance history of stoke or myocardial infarction within the past 3 months, recent (within 6 months) septal reduction therapy, present or planned pregnancy, and expected non-compliance with research protocol or treatment.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertrophic cardiomyopathy

Intervention(s)

Experimental group:Metoprolol Succinate Sustained-release Tablets combined with candesartan treatment;Control group:Metoprolol Succinate Sustained-release Tablets monotherapy;

Primary Outcome(s)

The changes in left ventricular mass from baseline to 24 months;

Secondary Outcome(s)

the change in the maximum thickness of left ventricular wall from baseline;the change in the maximum volume of the left atrium from baseline;the rehospitalization rate;cardiovascular adverse events including sudden cardiac death, malignant arrhythmia (ventricular tachycardia or ventricular fibrillation), heart failure and acute coronary syndrome;the change in the activity tolerance from baseline;the change in the cardiac diastolic function from baseline;

Source(s) of Monetary Support

The 5010 program of Sun Yat-sen University

Ethics review

Status: Approved
Approval date: 20/07/2017
Contact:

[e-mail]

Haifeng Lin

[phone]-8035

[e-mail]