Hypertrophic Cardiomyopathy Clinical Trial

Exercise in Genetic Cardiovascular Conditions

Summary

The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM) and long QT syndrome (LQTS).

Ancillary study Aim: To understand how the coronavirus epidemic is impacting psychological health and quality of life in the LIVE population

View Full Description

Full Description

Yale is the central site for this multicenter study. Patients with HCM and LQTS will be recruited via high-volume HCM and LQTS sites, patient-groups, and websites. Information about exercise participation will be acquired via interview and online instruments at enrollment and every six months for three years. Quality of Life questionnaires will be filled out at enrollment and at the end of the study. Participants will receive a Fitbit (pedometer) and will wear it initially for two weeks and then one week every three months. The Fitbit is used for assessment of exercise level only. Clinical records will be obtained from treating physicians. Participants will also be asked to call the central site if they experience syncope, appropriate ICD (implantable cardioverter defibrillator) shock, or resuscitated arrest. Information regarding the patient's activity at the time of event will then be obtained by phone interview. Follow-up clinical records will be obtained as indicated to corroborate endpoints.

The Ancillary study is optional. This will include all of the baseline questionnaires,as well as selected questions from the Epi-Pandemic Impacts Inventory.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome

Exclusion Criteria:

Individuals with Hypertrophic Cardiomyopathy with systolic or diastolic heart failure which precludes vigorous exercise will not be enrolled (NYHA III/IV)

Study is for people with:

Hypertrophic Cardiomyopathy

Estimated Enrollment:

4299

Study ID:

NCT02549664

Recruitment Status:

Completed

Sponsor:

Yale University

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There are 33 Locations for this study

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University of Arizona
Tucson Arizona, 85724, United States
University of California Irvine
Orange California, 92868, United States
University of California, San Diego (Rady's Children's Hospital)
San Diego California, 92123, United States
Stanford
Stanford California, 94305, United States
Yale University
New Haven Connecticut, 06420, United States
Children's National
Washington District of Columbia, 20010, United States
Miami Children's (Nicklaus Children's Hospital)
Miami Florida, 33155, United States
Lurie Children's
Chicago Illinois, 60611, United States
Indiana University
Indianapolis Indiana, 46202, United States
University of Iowa
Iowa City Iowa, 52242, United States
University of Louisville
Louisville Kentucky, 40202, United States
Johns Hopkins
Baltimore Maryland, 21287, United States
Tufts
Boston Massachusetts, 02111, United States
Boston Children's
Boston Massachusetts, 02115, United States
Brigham & Women's
Boston Massachusetts, 02115, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Children's Omaha
Omaha Nebraska, 68114, United States
NYU
New York New York, 10016, United States
Cincinnati Children's
Cincinnati Ohio, 45229, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oregon Health & Science
Portland Oregon, 97239, United States
Children's Hospital of Philadelphia (CHOP)
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
Vanderbilt University
Nashville Tennessee, 37232, United States
UT Southwestern
Dallas Texas, 75390, United States
Texas Children's
Houston Texas, 77030, United States
University of Utah (Primary Children's)
Salt Lake City Utah, 84113, United States
Seattle Children's
Seattle Washington, 98105, United States
Royal Prince Alfred Hospital/Sydney AU
Camperdown New South Wales, NSW 2, Australia
University of BC, Providence Health
Vancouver British Columbia, V6E 1, Canada
University of BC, Children's
Vancouver British Columbia, V6H 3, Canada
University of Toronto
Toronto Ontario, , Canada
Starship Children's Hospital
Grafton Auckland, , New Zealand
St. Georges, London
London England, SW17 , United Kingdom
Royal Brompton Hospital
London England, SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Estimated Enrollment:

4299

Study ID:

NCT02549664

Recruitment Status:

Completed

Sponsor:


Yale University

How clear is this clinincal trial information?

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