The effect of metoprolol in hypertrophic obstructive cardiomyopathy

Phase 1

• Conditions: Hypertrophic obstructive cardiomyopathy; MedDRA version: 20.0Level: LLTClassification code 10020876Term: Hypertrophic obstructive cardiomyopathySystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004478-32-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-14
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

- Informed consent
- Symptomatic patients, who fits the criteria for HCM ( wall thickness = 15 mm in one or more myocardial segments that is not explained by loading conditions.)
- LVOTG > 30 mmHg at rest and/or >50 mmHg at Valsalva’s maneuver or exercise
- = NYHA II

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

- Age < 18 years
- Know allergi to trial medication
- Contraindications to beta-blocker treatment
- Contraindications to Magnetic resonance scan including the contrast agent gadolineum
- Female patients who are pregnant (positive Plasma-HCG), nursing, or of childbearing potential while not practicing effective chemical contraceptive methods (i.e. oral, implanted, injectable or transdermal contraceptive hormones; intrauterine device)
- Pacemaker
- Treatment with Cordarone
- Atrial fibrillation/flutter at the time of examination
- Bradycardia < 49 beats/min
- Systolic blood pressure < 100 mmHg
- Trifasicular block
- Previous TASH (transcoronary ablation of septum hypertrophy) or myectomy
- Current abuse of alcohol and drugs
- Significant comorbidity or issue that makes the patient unsuitable fpr participation, judged by the investigator
- Patients who cannot give valid consent (e.g. mental illness or dementia)
- Patients who do not understand danish

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We want to quantify the effect of metoprololsuccinat on myocardial function, hemodynamics and symptoms in patients with hypertrophic obstructive cardiomyopathy.;Secondary Objective: not applicable;Primary end point(s): The primary endpoint is the reduction in Pulmonary Capillary Wedge Pressure (PCWP).<br>;Timepoint(s) of evaluation of this end point: The randomization codes will be unblinded when 27 patients with HOCM have finished full trial participation, after this the endpoint will be evaluated. Final endpoint evaluation is estimatede to 18-24 months after the first patient have been enrolled.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint is the increase in oxygen consumption, coronary flow reserve and mechanical efficiency and the reduction in interventriculare pressure gradients during exercise, NT-proBNP, heart failure symptoms and improvement of lifequality.;Timepoint(s) of evaluation of this end point: The randomization codes will be unblinded when 27 patients with HOCM have finished full trial participation, after this the endpoints will be evaluated. Final endpoint evaluation is estimatede to 18-24 months after the first patient have been enrolled.