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

Sponsor

University Hospital, Motol (Other)

Overall Status

Recruiting

CT.gov ID

NCT04133532

Collaborator

(none)

Enrollment

Location

Arms

45.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy	Drug: Metoprolol	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

We will enroll 50 patients and divide them into two arms. Initially, arm A will be given metoprolol and arm B will not. We will evaluate the two groups after a sufficient time period (three months) and after that, patients will cross-over to the other treatment strategy for three months followed by a final evaluation.We will enroll 50 patients and divide them into two arms. Initially, arm A will be given metoprolol and arm B will not. We will evaluate the two groups after a sufficient time period (three months) and after that, patients will cross-over to the other treatment strategy for three months followed by a final evaluation.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 5, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: metoprolol-no metoprolol 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.	Drug: Metoprolol metoprolol 50 mg daily for three months
Experimental: no metoprolol-metoprol 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.	Drug: Metoprolol metoprolol 50 mg daily for three months

Arm

Intervention/Treatment

Experimental: metoprolol-no metoprolol

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.

Drug: Metoprolol

metoprolol 50 mg daily for three months

Experimental: no metoprolol-metoprol

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.

Drug: Metoprolol

metoprolol 50 mg daily for three months

Outcome Measures

Primary Outcome Measures

Change in exercise tolerance with and without metoprolol [At baseline, after three months of metoprolol medication, after three months without metoprolol medication]
VO2max during bicycle ergometer exercise test

Secondary Outcome Measures

Change of quality of life with and without metoprolol: The Kansas City Cardiomyopathy Questionnaire [After three months of metoprolol medication, after three months without metoprolol medication]
The Kansas City Cardiomyopathy Questionnaire, score 0-100 (higher score means better outcome)
Change of concentration of biomarker of heart failure with and without metoprolol [After three months of metoprolol medication, after three months without metoprolol medication]
N-Terminal Pro-Brain Natriuretic Peptide concentration in blood sample
Change of concentration of a biomarker of myocardial injury with and without metoprolol [After three months of metoprolol medication, after three months without metoprolol medication]
High sensitivity troponin concentration in blood sample
Change in exercise induced pressure gradient in left ventricular outflow tract with and without metoprolol [After three months of metoprolol medication, after three months without metoprolol medication]
mmHg
Change in left ventricular diastolic function at rest with and without metoprolol [After three months of metoprolol medication, after three months without metoprolol medication]
Echocardiographic parameters of the transmitral flow and tissue Doppler

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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