"Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy".

Cardiac Rehabilitation Clinical Trial

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".

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178357
• Other study ID #: 2.1/I/17
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Krzysztof R Sadowski, MD
• Phone: +48223434408
• Email: ksadowski[@]ikard.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy

Intervention

Other:
• Cardiac rehabilitation + standard therapy
Patients with HCM subjected to cardiological rehabilitation
• Standard therapy
Standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling

Locations

Country	Name	City	State
Poland	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak VO2	Physical efficiency evaluated in the measurable parameter - peak VO2.	36 months