"Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy".

"Efficacy and Safety of Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy Without Left Ventricular Outflow Tract Obstruction With Preserved Systolic Function - Pilot Study".

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Other: Cardiac rehabilitation + standard therapy; Other: Standard therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 04-628
      • Recruiting
      • The Cardinal Stefan Wyszynski Institute of Cardiology
      • Contact: Krzysztof R Sadowski, MD; Phone Number: +483434408; Email: ksadowski@ikard.pl
      • Principal Investigator: Krzysztof Sadowski, MD
      • Principal Investigator: Ryszard Piotrowicz, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Standard therapy
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak VO2	Physical efficiency evaluated in the measurable parameter - peak VO2.	36 months

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland
• Investigators: Principal Investigator: Krzysztof Sadowski, The Cardinal Stefan Wyszynski Institute of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 24, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 2.1/I/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No