Clinical trial

Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy

Name

HCMBB

Description

In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation. The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.

Trial arms

Trial start

2020-03-05

Estimated PCD

2023-02-23

Trial end

2023-02-23

Status

Completed

Phase

Early phase I

Treatment

Metoprolol

metoprolol 50 mg daily for three months

Arms:

metoprolol-no metoprolol, no metoprolol-metoprol

Size

Primary endpoint

Change in exercise tolerance with and without metoprolol

At baseline, after three months of metoprolol medication, after three months without metoprolol medication

Eligibility criteria

Inclusion Criteria: * Patients post alcohol septal ablation * Pressure gradient in left ventricular outflow tract \<30 mmHg * Written consent to participate Exclusion Criteria: * History of atrial fibrillation * Symptoms of Class III or IV of New York Heart Association functional classification * Permanent pacemaker implant * Age above 75

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'We will enroll 50 patients and divide them into two arms. Initially, arm A will be given metoprolol and arm B will not. We will evaluate the two groups after a sufficient time period (three months) and after that, patients will cross-over to the other treatment strategy for three months followed by a final evaluation.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

Updated at

2023-05-10

1 organization

1 product

1 indication

Organization

University Hospital Motol

Product

Metoprolol

Indication

Hypertrophic Cardiomyopathy