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

University Hospital, Motol

Status and phase: Completed; Phase 4

Conditions: Hypertrophic Cardiomyopathy

Treatments: Drug: Metoprolol

Study type: Interventional

Funder types: Other

Identifiers

NCT04133532

HCMBB

Details and patient eligibility

About

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.

Full 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.

The investigators will enroll 50 patients that will meet all the inclusion criteria and will agree to participate in the trial. In patients with preceding beta-blocker medication, it will be discontinued and a washout period of one month will be provided. The investigators will assess baseline characteristics and then divide patients randomly into two arms based on their date of birth (even/odd days of the month).

Arm A will be given metoprolol 50 mg daily for three months, after this period the effect will be evaluated and metoprolol discontinued. A month-long washout period will follow and after an additional three months without metoprolol medication, patients will be reevaluated.

Arm B will be without metoprolol for three months and will be evaluated thereafter. Then the patients will be given metoprolol 50 mg daily for three months followed by a reevaluation.

The investigators will evaluate the effect of metoprolol by multiple methods at the end of the 5th and 9th months of the trial. Quality of life will be assessed by a questionnaire (The Kansas City Cardiomyopathy Questionnaire), exercise tolerance by a spiroergometry (VO2 max). A conventional echocardiographic examination and an examination focused on exercise-induced left ventricular outflow tract obstruction will be performed. The investigators will also measure NTproBNP from a blood sample as a laboratory marker of heart failure and high sensitive troponin as a marker of myocardial injury.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

metoprolol-no metoprolol

Experimental group

Description:

After a washout period of one month following discontinuation of preceding beta-blocker medication patients will be given metoprolol 50 mg daily. The effect will be evaluated after three months of treatment. After that, another one-month washout period will commence followed by three months without metoprolol medication. Then, a final reevaluation will be performed.

Treatment:

Drug: Metoprolol

no metoprolol-metoprol

Experimental group

Description:

After a one-month washout period following discontinuation of preceding beta-blocker medication patients will continue another three months without a metoprolol medication. After that, an evaluation will be performed. Then they will be given metoprolol 50 mg daily for three months followed by a reevaluation.

Treatment:

Drug: Metoprolol