Aims and objectives: The primary objective of this study is to assess whether a structured exercise program improves cardiac relaxing properties in patients with hypertrophic cardiomyopathy (HCM). Background: HCM is a hereditary disease in which the myocardium becomes thickened without an identifiable cause (other than genetic). It is the most common genetic cardiovascular disease with an estimated prevalence of 1/500 (i.e. 10.000 affected individuals in Denmark). The majority of patients with HCM suffers from shortness of breath and reduced exercise capacity due to increased left ventricular (LV) stiffness. Exercise training has been shown to improve exercise capacity and symptoms in patients with HCM, but the mechanisms responsible for this improvement are not known. Methods and materials: The study is a randomized, single blinded, prospective, controlled clinical trial. Eighty patients are recruited from outpatient clinics in the Capital Region of Denmark. Patients are randomized in a 1:1 ratio to 12 week of moderate-intensity exercise training or usual activity level. Assessments will include right heart catheterization, echocardiography, cardiopulmonary exercise testing, blood-samples, quality of life, and, in a subgroup of patients, cardiac magnetic resonance imaging. The primary end-point is change in LV filling pressure assessed as pulmonary capillary wedge pressure at 25 W workload. Expected outcome and perspectives: The investigators hypothesize that an exercise training program will reduce cardiac stiffness and improve symptoms in patients with HCM. Training of HCM patients has long been debated and the topic is poorly researched. The effects of exercise on hemodynamics in HCM patients are unknown and a better understanding of these mechanisms is pivotal for improving treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
61
12 weeks, 3 hours a week, moderate intensity exercise training
Rigshospitalet
Copenhagen, Denmark
Change from baseline to follow-up in PCWP at 25 W
Pulmonary capillary wedge pressure (mmHg)
Time frame: 12 weeks
Pulmonary capillary wedge pressure
At rest, at 25% and 50% of the maximum workload and at maximum workload ( measured as mmHg)
Time frame: 12 weeks
Workload adjusted Pulmonary capillary wedge pressure
At rest, at 25% and 50% of the maximum workload and at maximum workload, measured as mmHg/kg/W
Time frame: 12 weeks
Systemic vascular resistance
Resting and exercise systemic vascular resistance at rest, 25 W, 25% and 50% of the maximum workload and at maximum workload ( measured as mmHg)
Time frame: 12 weeks
Exercise capacity
Measured as watt at maximum workload
Time frame: 12 weeks
Heart rate
At rest, during exercise and at maximum exercise capacity (beats/min)
Time frame: 12 weeks
Blood pressure
At rest, at maximum workload, 6 minutes after cease of workload (mmHg)
Time frame: 12 weeks
Cardiac index
At rest, 25W and at maximum workload (L/min/m2):
Time frame: 12 weeks
Arterio-venous difference
At rest, 25W and at maximum workload (ml O2/L)and workload corrected (mlO2/L/W)
Time frame: 12 weeks
VO2 max
Measered as ml O2/min/kg
Time frame: 12 weeks
Quality of life questionnaire
Measured by Kansas City Cardiomyopathy score
Time frame: 12 weeks
NT-Pro-BNP
(pmol/L)
Time frame: 12 weeks
Troponin-T
(mmol/L)
Time frame: 12 weeks
Echocardiographic parameters
At rest: E/e'-ratio, E/A-ratio, deceleration time, LVOT gradient (mmHg). During exercise from 25W to maximum workload: E/e'-ratio, E/A-ratio, deceleration time, LVOT gradient(mmHg).
Time frame: 12 weeks
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