"Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy".

NCT03178357 | Unknown DMC

• 1 other identifier: 2.1/I/17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Peak VO2

  Physical efficiency evaluated in the measurable parameter - peak VO2.

  36 months

Study Arms (2)

HCM patients with CR

OTHER

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

HCM patients without CR (control group)

OTHER

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

Interventions

Cardiac rehabilitation + standard therapy OTHER

Patients with HCM subjected to cardiological rehabilitation

Also known as: Standard therapy

HCM patients with CR

Standard therapy OTHER

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

HCM patients without CR (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Stable general condition (1 month period).
• NYHA Class II and III.
• Preserved LV systolic function (LVEF ≥ 50%).
• Condition after ICD implantation.
• Written informed consent of the patient to participate in the Program.
• Completed eighteen years of age.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

The Cardinal Stefan Wyszyński Institute of Cardiology

Warsaw, Masovian Voivodeship, 04-628, Poland

RECRUITING

MeSH Terms

Interventions

Cardiac Rehabilitation; Standard of Care

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Krzysztof Sadowski

  The Cardinal Stefan Wyszyński Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof R Sadowski, MD

CONTACT

+48223434408; ksadowski@ikard.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 6, 2017
• Study Start: July 10, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)