Clinical trial NCT03178357: "Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy".
Official title: "Efficacy and Safety of Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy Without Left Ventricular Outflow Tract Obstruction With Preserved Systolic Function - Pilot Study".
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Rehabilitation
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hypertrophic cardiomyopathy (HCM) is the most common hereditary disease characterized by left ventricular hypertrophy and consequently left ventricular diastolic dysfunction. Its prevalence is estimated at around 0.2% in the general population. HCM is the most common cause of sudden cardiac death due to cardiovascular disease in young athletes, accounting for one third of deaths. HCM patients often have symptoms of heart failure. The ESC recommendations for heart failure (HF) from 2016 recommend exercise training regardless of ejection fraction to improve exercise capacity, quality of life, and reduction in hospitalizations due to HF. Meanwhile, for many years, HCM was equivalent to exercise training limitation. According to the 2014 ESC guidelines, it is recommended for patients with HCM to avoid sports practice. However the results of Edelmann et al. research, suggest that physical training leads to a significant clinical improvement in patients with diastolic dysfunction and thus may be beneficial in patients with HCM. In 2015 results of a first study were published (Klempfner et al.), which showed that the majority of HCM patients with moderate risk undergoing supervised physical training had improved physical performance and no significant adverse events were recorded. The study was limited by the small number of admitted patients (twenty), lack of control group and failure to perform cardio-pulmonary exercise test.

The main goal of the study will be to evaluate the effectiveness and safety of comprehensive cardiological rehabilitation and telerehabilitation in patients with hypertrophic cardiomyopathy without left ventricular outflow tract obstruction with preserved systolic function. The study is planned to include 30 patients with HCM subjected to physical training and 30 patients with HCM in the control group treated as standard according to current guidelines, not subjected to physical training.

Detailed description: The main goal of the study will be to evaluate the effectiveness and safety of comprehensive cardiological rehabilitation and telerehabilitation in patients with hypertrophic cardiomyopathy without left ventricular outflow tract obstruction with preserved systolic function. The study is planned to include 30 patients with HCM subjected to physical training and 30 patients with HCM in the control group treated as standard according to current guidelines, not subjected to physical training.

Eligibility criteria: Inclusion Criteria:

1. Patient with hypertrophic cardiomyopathy (defined in accordance with the ESC guidelines for the diagnosis and management of cardiomyopathy and hypertrophy in 2014): thickness ≥ 15 mm of one or more segments of the left ventricular wall measured using any imaging technique \[echocardiography, cardiac magnetic resonance or computed tomography\] which can not be explained solely by the left ventricular loading conditions) without left ventricular outflow tract obstruction at rest: gradient \<30 mmHg.
2. Stable general condition (1 month period).
3. NYHA Class II and III.
4. Preserved LV systolic function (LVEF ≥ 50%).
5. Condition after ICD implantation.
6. Written informed consent of the patient to participate in the Program.
7. Completed eighteen years of age.

Exclusion Criteria:

1. Complex life-threatening ventricular arrhythmias that can not be treated.
2. Uncontrolled hypertension.
3. Advanced atrio-ventricular block.
4. Myocarditis or pericarditis (up to 6 months).
5. Symptomatic aortic stenosis.
6. Acute systemic illness.
7. Intracardiac thrombosis.
8. Significant ischaemia during low intensity exercise test (2 METS, 50W).
9. Uncontrolled diabetes.
10. Pulmonary embolism (up to 6 months).
11. Thrombophlebitis.
12. New episode of AF/Afl.
13. Decrease in systolic blood pressure during exercise.
14. Co-morbidities that limit exercise tolerance and prevent exercise.

Primary outcomes:
measure: Peak VO2
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszyński Institute of Cardiology
state: Mazowieckie
Study officials:
affiliation: The Cardinal Stefan Wyszyński Institute of Cardiology
name: Krzysztof Sadowski
role: PRINCIPAL_INVESTIGATOR
References: