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The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy.

NCT03532802 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-29

No results posted yet for this study

Summary

Hypertrophic obstructive cardiomyopathy (HOCM) patients often develop disabling symptoms of heart failure. Current treatment strategies are predicated on the empirical use of long-standing drugs, such as beta-adrenergics, although with little evidence supporting their clinical benefit in this disease. Metoprolol is currently the most widely used beta-blocker in symptomatic HOCM patients, but a randomized, placebo-controlled trial, that looks at the effect in HOCM patients has never been conducted. No studies of HOCM combine invasive pressure measurement with exercise and echocardiography. All previous studies, both invasive and echocardiographic, have been conducted during rest, and not during exercise. Symptoms of HOCM patients are function-related, and exercise testing is essential to assess the condition and the effect of drugs.

Conditions

Interventions

DRUG

Metoprolol Succinate

1. week: uptitration with 50 mg capsules per day, until maximum dosage of 150 mg´s/day. 2. week: steady state treatment with the maximum tolerated dose of the 1.week.

DRUG

Placebo oral capsule

1. week: uptitration with 1 capsule per day, until maximum tolerated dosage of 3 capsules/day. 2. week: steady state treatment with the maximum tolerated dose of the 1. week

Sponsors & Collaborators

  • Steen Hvitfeldt Poulsen

    lead OTHER

Principal Investigators

  • Steen Hvitfeldt Poulsen, MD · Aa

  • Morten Kvistholm Jensen, MD, PhD · Aarhus University Hospital, Department of Cardiology

  • Torsten Bloch Rasmussen, MD, PhD · Aarhus University Hospital, Department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-09-01
Completion
2020-09-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532802 on ClinicalTrials.gov