NCT01518114

Brief Summary

Exercise training (ET) is highly beneficial in heart failure patients and has been suggested to confer significant symptomatic and functional improvements in patients with diastolic dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a structured ET program in symptomatic HCM patients.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

1.1 years

First QC Date

January 10, 2012

Last Update Submit

January 26, 2012

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic CardiomyopathyExercise TrainingCardiac RehabilitationHeart Failure

Outcome Measures

Primary Outcomes (2)

  • Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation

    End point to be assessed by cardiopulmonary testing are pre- and post exercise training improvement as expressed by the changes in : VO2 MAX, exercise duration, duration to ventilatory threshold(VT).

    6 months

  • Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy

    Safety endpoonts: 1) Clinicaly significant arrhythmia during exercise training 2)MACE during follow-up period (ACS, Stroke or Death) 3)Exercise Related Injury 4) Episodes of syncope

    12 months

Secondary Outcomes (1)

  • Secondary Endpoints:

    12 months

Study Arms (2)

Exercise Training

EXPERIMENTAL

Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale. Exercise prescription will be based upon cardiopulmonary test done at baseline.

Behavioral: Exercise Training

Best Medical Care

ACTIVE COMPARATOR

Advanced HCM patients who are eligible to participate in the study but cannot do so for technical reasons will be invited to participate in the project as a control group.These subjects will continue their regular follow up in the Cardiomyopathy Clinic and their usual voluntary physical activity at home.

Behavioral: Exercise Training

Interventions

Exercise TrainingBEHAVIORAL

Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.

Best Medical CareExercise Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertrophic Cardiomyopathy
  • NYHA 3
  • Maximal left ventricular wall thickness \> 20 mm
  • Age \>18

You may not qualify if:

  • Severe non-cardiac limitations of functional capacity such as neurological illness, lung disease, peripheral vascular or orthopedic problem, etc.
  • Patients state post resuscitation for malignant ventricular arrhythmia.
  • History of effort induced syncope, complex ventricular arrhythmia or atrial fibrillation.
  • An exercise-induced decrease in blood pressure
  • Severe left ventricular outflow obstruction defined as resting outflow gradient \> 50 mmHg on maximal therapy
  • Atrial fibrillation with a poorly controlled ventricular response
  • Advanced hypokinetic stage of HCM defined as LVEF \< 40%
  • Congestive heart failure of angina FC IV according to NYHA or CCS respectively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Hashomer , Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicHeart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Arad Michael, MD

CONTACT

Michael.Arad@sheba.health.gov.il

Robert Klempfner, MD

CONTACT

+972525506852klempfner@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 25, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2013

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

IL(1)