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

NCT04133532 | Completed Phase 4

• 1 other identifier: HCMBB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

Exercise tolerance; NTproBNP; Left ventricular outflow tract obstruction; Quality of life; Diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in exercise tolerance with and without metoprolol

  VO2max during bicycle ergometer exercise test

  At baseline, after three months of metoprolol medication, after three months without metoprolol medication

Secondary Outcomes (5)

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

  After three months of metoprolol medication, after three months without metoprolol medication

• Change of concentration of biomarker of heart failure with and without metoprolol

  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

  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

  After three months of metoprolol medication, after three months without metoprolol medication

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

  After three months of metoprolol medication, after three months without metoprolol medication

Study Arms (2)

metoprolol-no metoprolol

EXPERIMENTAL

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

no metoprolol-metoprol

EXPERIMENTAL

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

Interventions

Metoprolol DRUG

metoprolol 50 mg daily for three months

metoprolol-no metoprolol; no metoprolol-metoprol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients post alcohol septal ablation
• Pressure gradient in left ventricular outflow tract \<30 mmHg
• Written consent to participate

You may not qualify if:

• History of atrial fibrillation
• Symptoms of Class III or IV of New York Heart Association functional classification
• Permanent pacemaker implant
• Age above 75

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

Motol University Hospital

Prague, Czech Republic, 15000, Czechia

Location

Related Publications (9)

• 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. No abstract available.

  PMID: 22068434 BACKGROUND

• Maron BJ, McKenna WJ, Danielson GK, Kappenberger LJ, Kuhn HJ, Seidman CE, Shah PM, Spencer WH 3rd, Spirito P, Ten Cate FJ, Wigle ED; Task Force on Clinical Expert Consensus Documents. American College of Cardiology; Committee for Practice Guidelines. European Society of Cardiology. American College of Cardiology/European Society of Cardiology clinical expert consensus document on hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents and the European Society of Cardiology Committee for Practice Guidelines. J Am Coll Cardiol. 2003 Nov 5;42(9):1687-713. doi: 10.1016/s0735-1097(03)00941-0. No abstract available.

  PMID: 14607462 BACKGROUND

• HARRISON DC, BRAUNWALD E, GLICK G, MASON DT, CHIDSEY CA, ROSS J Jr. EFFECTS OF BETA ADRENERGIC BLOCKADE ON THE CIRCULATION WITH PARTICULAR REFERENCE TO OBSERVATIONS IN PATIENTS WITH HYPERTROPHIC SUBAORTIC STENOSIS. Circulation. 1964 Jan;29:84-98. doi: 10.1161/01.cir.29.1.84. No abstract available.

  PMID: 14105035 BACKGROUND

• Cohen LS, Braunwald E. Amelioration of angina pectoris in idiopathic hypertrophic subaortic stenosis with beta-adrenergic blockade. Circulation. 1967 May;35(5):847-51. doi: 10.1161/01.cir.35.5.847. No abstract available.

  PMID: 6067064 BACKGROUND

• Fananapazir L, Chang AC, Epstein SE, McAreavey D. Prognostic determinants in hypertrophic cardiomyopathy. Prospective evaluation of a therapeutic strategy based on clinical, Holter, hemodynamic, and electrophysiological findings. Circulation. 1992 Sep;86(3):730-40. doi: 10.1161/01.cir.86.3.730.

  PMID: 1516184 BACKGROUND

• Gilligan DM, Chan WL, Joshi J, Clarke P, Fletcher A, Krikler S, Oakley CM. A double-blind, placebo-controlled crossover trial of nadolol and verapamil in mild and moderately symptomatic hypertrophic cardiomyopathy. J Am Coll Cardiol. 1993 Jun;21(7):1672-9. doi: 10.1016/0735-1097(93)90386-f.

  PMID: 8496536 BACKGROUND

• Nistri S, Olivotto I, Maron MS, Ferrantini C, Coppini R, Grifoni C, Baldini K, Sgalambro A, Cecchi F, Maron BJ. beta Blockers for prevention of exercise-induced left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. Am J Cardiol. 2012 Sep 1;110(5):715-9. doi: 10.1016/j.amjcard.2012.04.051. Epub 2012 May 24.

  PMID: 22633205 BACKGROUND

• Fifer MA, Vlahakes GJ. Management of symptoms in hypertrophic cardiomyopathy. Circulation. 2008 Jan 22;117(3):429-39. doi: 10.1161/CIRCULATIONAHA.107.694158. No abstract available.

  PMID: 18212300 BACKGROUND

• Desai MY, Bhonsale A, Patel P, Naji P, Smedira NG, Thamilarasan M, Lytle BW, Lever HM. Exercise echocardiography in asymptomatic HCM: exercise capacity, and not LV outflow tract gradient predicts long-term outcomes. JACC Cardiovasc Imaging. 2014 Jan;7(1):26-36. doi: 10.1016/j.jcmg.2013.08.010. Epub 2013 Nov 27.

  PMID: 24290569 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Ventricular Outflow Obstruction, Left

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Josef Veselka, MD, PhD

  Motol University Hospital, Department of Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, resident in cardiology department

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 21, 2019
• Study Start: March 5, 2020
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

CZ (1)