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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participants will be treated with alcohol septal ablation.
Participants will be treated with surgical septal myectomy.
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands
RECRUITINGMetabolic Equivalent (METs) assessed with a bicycle ergometry exercise test
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.
Time frame: 1 year after the invasive treatment
Number of participants with all-cause mortality
Time frame: Follow up will be 1,3 and 5 years
Number of participants with cardiovascular mortality
Time frame: Follow up will be 1,3 and 5 years
Number of participants with transient Ischemic Attack
Time frame: Follow up will be 1,3 and 5 years
Number of participants with hospital Readmittance
Time frame: Follow up will be 1,3 and 5 years
Number of participants with with occurrence of atrial fibrillation
Time frame: Follow up will be 1,3 and 5 years
Number of participants with ventricular arrhythmias
Time frame: Follow up will be 1,3 and 5 years
Number of participants with with complete heart block requiring permanent pacemaker implantation
Time frame: Follow up will be 1,3 and 5 years
Number of participants with major bleeding
Bleeding rate will be analysed using Bleeding Academic Research Consortium (type 3,4 or 5), TIMI major and VARC major criteria.
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Time frame: First 30 days
Number of participants with re-intervention
One more time need for Alcohol septal ablation or surgical septal myectomy
Time frame: Follow up will be 1,3 and 5 years
Blood sample results
Troponin T (in ug/l)
Time frame: Follow up will be 1,3 and 5 years
Blood sample results
N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP in pg/ml)
Time frame: Follow up will be 1,3 and 5 years
Blood sample results
Creatine-kinase (CK in U/l)
Time frame: Follow up will be 1,3 and 5 years
Quality of life evaluation using the The Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Time frame: Follow up will be 1,3 and 5 years
Cardiac Magnetic Resonance Imaging (CMR) parameters
Interventricular septal thickness (mm), atrial diameter (mm) , left and right ventricular diameter (mm), left ventricle end diastolic volume (ml), left ventricle systolic volume (ml)
Time frame: Follow up will be 1,3 and 5 years
Cardiac Magnetic Resonance Imaging (CMR) parameters
Left ventricle end diastolic volume (ml), left ventricle systolic volume (ml)
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Left ventricle ejection fraction (%)
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Left ventricle outflow tract gradient (mmHg)
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Left ventricular internal systolic and diastolic dimension (cm)
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Atrial diameter (ml/m2)
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Valvular function
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Right ventricular systolic pressure (mmHg)
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Interventricular septal thickness (mm)
Time frame: Follow up will be 1,3 and 5 years