The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy.

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steen Hvitfeldt Poulsen
• Treatments: Metoprolol

Criteria

Inclusion Criteria:

• Wall thickness ≥ 15 mm in one or more myocardial segments that is not explained by loading conditions.

• LVOT gradient > 30 mmHg at rest and/or > 50 mmHg at Valsalva's maneuver or exercise

• New York Heart Association Functional class (NYHA) ≥ II

Exclusion Criteria:

• Age < 18 years

• Known allergy to trial medicine

• Contraindications to beta-blocker treatment

• Contraindications to Magnetic resonans scan, including contraindication to the contrast agent gadolinium.

• Female patients who are pregnant (positive plasma-HCG), breastfeeding or of child-bearing potential while not practicing effective chemical contraceptive hormones.

• In case of patients having a pacemaker, they may not be pace-dependent.

• Treatment with Amiodarone

• Atrial fibrillation/flutter at the time of examination

• Bradycardia < 49 beats/min

• Systolic blood pressure < 100 mmHg

• Trifascicular block

• Previous transcoronary ablation of septum hypertrophy (TASH) or myectomy

• Current abuse of alcohol and/or drugs

• Significant co-morbidity or issues that makes the patient unsuitable for participation, judged by the investigator

• Patients who cannot give valid consent (e.g. mental illness or dementia)

• Patients who do not understand danish