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

May 9, 2023 updated by: Hana Hnátová, University Hospital, Motol
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Praha, Czech Republic, Czechia, 15000
        • Motol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
After three months of metoprolol medication, after three months without metoprolol medication
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
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
Time Frame: After three months of metoprolol medication, after three months without metoprolol medication
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
Time Frame: After three months of metoprolol medication, after three months without metoprolol medication
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
Time Frame: After three months of metoprolol medication, after three months without metoprolol medication
Echocardiographic parameters of the transmitral flow and tissue Doppler
After three months of metoprolol medication, after three months without metoprolol medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Motol

Investigators

  • Study Director: Josef Veselka, MD, PhD, Motol University Hospital, Department of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Actual)

February 23, 2023

Study Completion (Actual)

February 23, 2023

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCMBB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertrophic Cardiomyopathy

Clinical Trials on Metoprolol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe