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

Primary Purpose

Hypertrophic Cardiomyopathy

Status
Completed
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
Metoprolol
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Exercise tolerance, NTproBNP, Left ventricular outflow tract obstruction, Quality of life, Diastolic dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Motol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

metoprolol-no metoprolol

no metoprolol-metoprol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in exercise tolerance with and without metoprolol
VO2max during bicycle ergometer exercise test

Secondary Outcome Measures

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)
Change of concentration of biomarker of heart failure with and without metoprolol
N-Terminal Pro-Brain Natriuretic Peptide concentration in blood sample
Change of concentration of a biomarker of myocardial injury with and without metoprolol
High sensitivity troponin concentration in blood sample
Change in exercise induced pressure gradient in left ventricular outflow tract with and without metoprolol
mmHg
Change in left ventricular diastolic function at rest with and without metoprolol
Echocardiographic parameters of the transmitral flow and tissue Doppler

Full Information

First Posted
October 16, 2019
Last Updated
May 9, 2023
Sponsor
University Hospital, Motol
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1. Study Identification

Unique Protocol Identification Number
NCT04133532
Brief Title
Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy
Official Title
Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Motol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
Exercise tolerance, NTproBNP, Left ventricular outflow tract obstruction, Quality of life, Diastolic dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metoprolol-no metoprolol
Arm Type
Experimental
Arm Description
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.
Arm Title
no metoprolol-metoprol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Description
metoprolol 50 mg daily for three months
Primary Outcome Measure Information:
Title
Change in exercise tolerance with and without metoprolol
Description
VO2max during bicycle ergometer exercise test
Time Frame
At baseline, after three months of metoprolol medication, after three months without metoprolol medication
Secondary Outcome Measure Information:
Title
Change of quality of life with and without metoprolol: The Kansas City Cardiomyopathy Questionnaire
Description
The Kansas City Cardiomyopathy Questionnaire, score 0-100 (higher score means better outcome)
Time Frame
After three months of metoprolol medication, after three months without metoprolol medication
Title
Change of concentration of biomarker of heart failure with and without metoprolol
Description
N-Terminal Pro-Brain Natriuretic Peptide concentration in blood sample
Time Frame
After three months of metoprolol medication, after three months without metoprolol medication
Title
Change of concentration of a biomarker of myocardial injury with and without metoprolol
Description
High sensitivity troponin concentration in blood sample
Time Frame
After three months of metoprolol medication, after three months without metoprolol medication
Title
Change in exercise induced pressure gradient in left ventricular outflow tract with and without metoprolol
Description
mmHg
Time Frame
After three months of metoprolol medication, after three months without metoprolol medication
Title
Change in left ventricular diastolic function at rest with and without metoprolol
Description
Echocardiographic parameters of the transmitral flow and tissue Doppler
Time Frame
After three months of metoprolol medication, after three months without metoprolol medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Veselka, MD, PhD
Organizational Affiliation
Motol University Hospital, Department of Cardiology
Official's Role
Study Director
Facility Information:
Facility Name
Motol University Hospital
City
Praha
State/Province
Czech Republic
ZIP/Postal Code
15000
Country
Czechia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22068434
Citation
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Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy

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