Hypertrophic Cardiomyopathy
Conditions
Keywords
Exercise tolerance, NTproBNP, Left ventricular outflow tract obstruction, Quality of life, Diastolic dysfunction
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.
Interventions
DRUGMetoprolol
metoprolol 50 mg daily for three months
Sponsors
University Hospital, Motol
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise tolerance with and without metoprolol | At baseline, after three months of metoprolol medication, after three months without metoprolol medication | VO2max during bicycle ergometer exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | After three months of metoprolol medication, after three months without metoprolol medication | N-Terminal Pro-Brain Natriuretic Peptide concentration in blood sample |
| 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 | High sensitivity troponin concentration in blood sample |
| 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 | mmHg |
| Change in left ventricular diastolic function at rest with and without metoprolol | After three months of metoprolol medication, after three months without metoprolol medication | Echocardiographic parameters of the transmitral flow and tissue Doppler |
Countries
Czechia
Outcome results
None listed