Cardiac Rehabilitation in Patients With HCM Without LV Outflow Tract Obstruction With Preserved EF – Pilot Study


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Verified June 2017 by Institute of Cardiology, Warsaw, Poland

Sponsor:

Information provided by (Responsible Party):

Institute of Cardiology, Warsaw, Poland

ClinicalTrials.gov Identifier:

NCT03178357

First received: June 5, 2017

Last updated: June 5, 2017

Last verified: June 2017

Hypertrophic cardiomyopathy (HCM) is the most common hereditary disease characterized by left ventricular hypertrophy and consequently left ventricular diastolic function. 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 that patients with HCM avoid sports practice. Edelmann et al., however, suggest that physical training brings significant improvement in patients with diastolic dysfunction and thus may be beneficial in patients with HCM. In 2015, Klempfner et al. published the results of a first study, which showed that the majority of HCM patients with moderate risk undergoing supervised physical training had improved physical performance, no significant adverse events were recorded. The study was limited by the small number of admitted patients (twenty), lack of control and failure to perform cardio-pulmonary exercise test. The main goal of our 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.

Cardiac Rehabilitation Other: Cardiac rehabilitation + standard therapy
Other: Standard therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
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”

Primary Outcome Measures:

Estimated Enrollment: 30
Anticipated Study Start Date: June 6, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
HCM patients with CR

30 HCM patients treated as standard subjected to 4-week hospital cardiac rehabilitation (CR) including psychological care (counseling and / or psychoeducation) and physical training followed by 8 weeks of telerehabilitation in the patient’s home (cardiac rehabilitation + standard therapy)

Other: Cardiac rehabilitation + standard therapy

Patients with HCM subjected to cardiological rehabilitation

Other Name: Standard therapy

HCM patients without CR (control group)

30 HCM patients in control group – standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling (standard therapy)

Other: Standard therapy

Standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling

The main goal of our 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. State 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 epizode of AF/Afl.
  13. Decrease in systolic blood pressure during exercise.
  14. Co-morbidities that limit exercise tolerance and prevent exercise.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03178357

Institute of Cardiology, Warsaw, Poland

Principal Investigator: Krzysztof Sadowski The Cardinal Stefan Wyszyński Institute of Cardiology

Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT03178357     History of Changes
Other Study ID Numbers: 2.1/I/17
Study First Received: June 5, 2017
Last Updated: June 5, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on June 06, 2017