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

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133532
• Other study ID #: HCMBB
• Status: Completed
• Phase: Phase 4
• Start date: March 5, 2020
• Est. completion date: February 23, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Drug:
• Metoprolol
metoprolol 50 mg daily for three months

Locations

Country	Name	City	State
Czechia	Motol University Hospital	Praha	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	After three months of metoprolol medication, after three months without metoprolol medication
Secondary	Change of concentration of biomarker of heart failure with and without metoprolol	N-Terminal Pro-Brain Natriuretic Peptide concentration in blood sample	After three months of metoprolol medication, after three months without metoprolol medication
Secondary	Change of concentration of a biomarker of myocardial injury with and without metoprolol	High sensitivity troponin concentration in blood sample	After three months of metoprolol medication, after three months without metoprolol medication
Secondary	Change in exercise induced pressure gradient in left ventricular outflow tract with and without metoprolol	mmHg	After three months of metoprolol medication, after three months without metoprolol medication
Secondary	Change in left ventricular diastolic function at rest with and without metoprolol	Echocardiographic parameters of the transmitral flow and tissue Doppler	After three months of metoprolol medication, after three months without metoprolol medication