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"Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy".

Primary Purpose

Cardiac Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Cardiac rehabilitation + standard therapy
Standard therapy
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Cardinal Stefan Wyszyński Institute of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

HCM patients with CR

HCM patients without CR (control group)

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Peak VO2
Physical efficiency evaluated in the measurable parameter - peak VO2.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2017
Last Updated
March 24, 2019
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT03178357
Brief Title
"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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HCM patients with CR
Arm Type
Other
Arm Description
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)
Arm Title
HCM patients without CR (control group)
Arm Type
Other
Arm Description
30 HCM patients in control group - standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling (standard therapy)
Intervention Type
Other
Intervention Name(s)
Cardiac rehabilitation + standard therapy
Other Intervention Name(s)
Standard therapy
Intervention Description
Patients with HCM subjected to cardiological rehabilitation
Intervention Type
Other
Intervention Name(s)
Standard therapy
Intervention Description
Standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling
Primary Outcome Measure Information:
Title
Peak VO2
Description
Physical efficiency evaluated in the measurable parameter - peak VO2.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krzysztof R Sadowski, MD
Phone
+48223434408
Email
ksadowski@ikard.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Sadowski
Organizational Affiliation
The Cardinal Stefan Wyszyński Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cardinal Stefan Wyszyński Institute of Cardiology
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-628
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof R Sadowski, MD
Phone
+483434408
Email
ksadowski@ikard.pl
First Name & Middle Initial & Last Name & Degree
Krzysztof Sadowski, MD
First Name & Middle Initial & Last Name & Degree
Ryszard Piotrowicz, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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"Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy".

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