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Metoprolol in Post-ASA Hypertrophic Cardiomyopathy

NCT04133532Phase 4

Key facts

Status: Completed
Start: Mar 2020
Primary completion: Feb 2023
Countries: 1
Sponsor: Motol University Hospital
Modality: Small Molecules

Drugs: metoprolol
Conditions: hypertrophic cardiomyopathy (HCM)

Overview

Phase 4, randomised, open-label trial of metoprolol in hypertrophic cardiomyopathy (HCM) (2 arms), sponsored by Motol University Hospital. Primary endpoint: Change in exercise tolerance (VO2 max) at 6 months. Started Mar 2020; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Metoprolol First
Metoprolol -> Washout -> No Metoprolol
No Metoprolol First
No Metoprolol -> Metoprolol

Endpoints

Primary

Change in exercise tolerance (VO2 max)6 months

Secondary

Change of quality of life (Kansas City Cardiomyopathy Questionnaire)6 months
Change of concentration of biomarker of heart failure (NT-proBNP)6 months
Change of concentration of biomarker of myocardial injury (High sensitive troponin)6 months
Change in exercise induced pressure gradient in left ventricular outflow tract6 months
Change in left ventricular diastolic function at rest6 months

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