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

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ClinicalTrials.gov Identifier: NCT04133532
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hana Hnátová, University Hospital, Motol

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.

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Drug: Metoprolol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : February 1, 2021


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133532


Contacts
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Contact: Hana Hnátová, MD 00420603574669 hanka.hnat@gmail.com

Sponsors and Collaborators
University Hospital, Motol
Investigators
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Study Director: Josef Veselka, MD, PhD Motol University Hospital, Department of Cardiology

Publications:
Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 13;124(24):e783-831. doi: 10.1161/CIR.0b013e318223e2bd. Epub 2011 Nov 8.

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Responsible Party: Hana Hnátová, medical doctor, resident in cardiology department, University Hospital, Motol
ClinicalTrials.gov Identifier: NCT04133532     History of Changes
Other Study ID Numbers: HCMBB
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hana Hnátová, University Hospital, Motol:
Exercise tolerance
NTproBNP
Left ventricular outflow tract obstruction
Quality of life
Diastolic dysfunction
Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action