Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Metoprolol
Intervention type(s): Drug
Intervention description(s): metoprolol 50 mg daily for three months
Intervention MeSH terms: Metoprolol
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise tolerance; NTproBNP; Left ventricular outflow tract obstruction; Quality of life; Diastolic dysfunction