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NCT Number: NCT04133532

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

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction Ventricular Outflow Obstruction, Left

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Motol University Hospital

Prague, Czech Republic, 15000, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metoprolol

Drug

metoprolol 50 mg daily for three months

Primary outcomes

  1. Change in exercise tolerance with and without metoprolol

    Time frame: At baseline, after three months of metoprolol medication, after three months without metoprolol medication

    VO2max during bicycle ergometer exercise test

Secondary outcomes

  1. Change of quality of life with and without metoprolol: The Kansas City Cardiomyopathy Questionnaire

    Time frame: 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)

  2. Change of concentration of biomarker of heart failure with and without metoprolol

    Time frame: After three months of metoprolol medication, after three months without metoprolol medication

    N-Terminal Pro-Brain Natriuretic Peptide concentration in blood sample

  3. Change of concentration of a biomarker of myocardial injury with and without metoprolol

    Time frame: After three months of metoprolol medication, after three months without metoprolol medication

    High sensitivity troponin concentration in blood sample

  4. Change in exercise induced pressure gradient in left ventricular outflow tract with and without metoprolol

    Time frame: After three months of metoprolol medication, after three months without metoprolol medication

    mmHg

  5. Change in left ventricular diastolic function at rest with and without metoprolol

    Time frame: After three months of metoprolol medication, after three months without metoprolol medication

    Echocardiographic parameters of the transmitral flow and tissue Doppler

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2019
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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