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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Drug: Metoprolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metoprolol-no metoprolol<br>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<br>* metoprolol 50 mg daily for three months<br>|
| Experimental: no metoprolol-metoprol<br>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<br>* metoprolol 50 mg daily for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise tolerance with and without metoprolol | VO2max during bicycle ergometer exercise test | At baseline, after three months of metoprolol medication, after three months without metoprolol medication | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise tolerance, NTproBNP, Left ventricular outflow tract obstruction, Quality of life, Diastolic dysfunction