Hypertrophic Cardiomyopathy
Conditions
Brief summary
The aim of this randomized trial is to compare the improvement in exercise capacity among patients with highly symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment who undergo alcohol septal ablation (ASA) or surgical septal myectomy (SSM).
Detailed description
This is a prospective, multicentre, open label, randomized controlled, non-inferiority trial (RCT) with a 1:1 randomization to alcohol septal ablation or surgical septal myectomy in patients with hypertrophic obstructive cardiomyopathy (HOCM) between 40-75 year of age with symptoms and/or syncope due to HOCM despite medical therapy. A total of 100 patients will be included. All patients will be evaluated with bicycle ergometry exercise test, MRI and 2D-echo before and 1 year after invasive treatment. Follow-up will be at 1,3 and 5 years.
Interventions
PROCEDUREAlcohol Septal Ablation
Participants will be treated with alcohol septal ablation.
PROCEDURESurgical Septal Myectomy
Participants will be treated with surgical septal myectomy.
Sponsors
Erasmus Medical Center
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 40-75 years including 40 and 75 years of age 2. HOCM eligible for both SSM and ASA by a heart team (multidisciplinary team) and core lab. 3. Left ventricle outflow tract (LVOT) obstruction \> 30mmHg at rest or during physiological provocation by transthoracic echocardiogram 4. Symptomatic (New York Heart Association classification (NYHA) \>1 or Canadian Cardiovascular Society (CCS) class \>1) and/or syncope due to HOCM
Exclusion criteria
1. Unable to give informed consent 2. A life expectancy of less than 1 year 3. Concomitant (structural valve disease, aorta, rhythm, CABG) surgery during the same session 4. Not able to perform bicycle ergometry exercise test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test | 1 year after the invasive treatment | The primary endpoint is the improvement of the exercise capacity in the form of Metabolic Equivalent (METs) which will be assessed with a bicycle ergometry exercise test (difference in exercise capacity in Metabolic Equivalents) performed before and 1 year after invasive treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with cardiovascular mortality | Follow up will be 1,3 and 5 years | — |
| Number of participants with transient Ischemic Attack | Follow up will be 1,3 and 5 years | — |
| Number of participants with hospital Readmittance | Follow up will be 1,3 and 5 years | — |
| Number of participants with with occurrence of atrial fibrillation | Follow up will be 1,3 and 5 years | — |
| Number of participants with ventricular arrhythmias | Follow up will be 1,3 and 5 years | — |
| Number of participants with with complete heart block requiring permanent pacemaker implantation | Follow up will be 1,3 and 5 years | — |
| Number of participants with all-cause mortality | Follow up will be 1,3 and 5 years | — |
| Number of participants with re-intervention | Follow up will be 1,3 and 5 years | One more time need for Alcohol septal ablation or surgical septal myectomy |
| Blood sample results | Follow up will be 1,3 and 5 years | Troponin T (in ug/l) |
| Quality of life evaluation using the The Kansas City Cardiomyopathy Questionnaire (KCCQ) | Follow up will be 1,3 and 5 years | In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. For brevity, only the performance characteristics of the overall summary score are presented in this discussion. |
| Cardiac Magnetic Resonance Imaging (CMR) parameters | Follow up will be 1,3 and 5 years | Interventricular septal thickness (mm), atrial diameter (mm) , left and right ventricular diameter (mm), left ventricle end diastolic volume (ml), left ventricle systolic volume (ml) |
| Transthoracic echocardiogram | Follow up will be 1,3 and 5 years | Left ventricle ejection fraction (%) |
| Number of participants with major bleeding | First 30 days | Bleeding rate will be analysed using Bleeding Academic Research Consortium (type 3,4 or 5), TIMI major and VARC major criteria. |
Countries
Netherlands
Outcome results
None listed