Exercise in Genetic Cardiovascular Conditions
- Conditions
- Hypertrophic CardiomyopathyLong QT Syndrome
- Registration Number
- NCT02549664
- Lead Sponsor
- Yale University
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4299
- Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome
- Individuals with Hypertrophic Cardiomyopathy with systolic or diastolic heart failure which precludes vigorous exercise will not be enrolled (NYHA III/IV)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare composite risk of death, cardiac arrest, ventricular arrhythmias, or syncope in individuals with HCM or LQTS who are participating in moderate or vigorous exercise and in sedentary individuals. Five years Collect information for death, resuscitated arrest, syncope, appropriate ICD shock , during exercise or at other times, through records from the provider and patient interviews
- Secondary Outcome Measures
Name Time Method Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli) Five years Will assess using Pediatric Cardiac Quality of Life Inventory (Pcqli)
Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL) Five Years Will assess using Pediatric Quality of Life Inventory (PedsQL)
Physical Quality of Life assessed using Health Status Questionnaire (SF36) Quality of Life for Adults Five Years Will assess using Health Status Questionnaire (SF36) Quality of Life for Adults
Trial Locations
- Locations (36)
Lurie Children's
🇺🇸Chicago, Illinois, United States
University of California Irvine
🇺🇸Orange, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Children's Omaha
🇺🇸Omaha, Nebraska, United States
Stanford
🇺🇸Stanford, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
NYU
🇺🇸New York, New York, United States
Miami Children's (Nicklaus Children's Hospital)
🇺🇸Miami, Florida, United States
Cincinnati Children's
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Philadelphia (CHOP)
🇺🇸Philadelphia, Pennsylvania, United States
Tufts
🇺🇸Boston, Massachusetts, United States
Boston Children's
🇺🇸Boston, Massachusetts, United States
Brigham & Women's
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Texas Children's
🇺🇸Houston, Texas, United States
Seattle Children's
🇺🇸Seattle, Washington, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of California, San Diego (Rady's Children's Hospital)
🇺🇸San Diego, California, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
University of Utah (Primary Children's)
🇺🇸Salt Lake City, Utah, United States
Royal Prince Alfred Hospital/Sydney AU
🇦🇺Camperdown, New South Wales, Australia
University of BC, Providence Health
🇨🇦Vancouver, British Columbia, Canada
University of BC, Children's
🇨🇦Vancouver, British Columbia, Canada
University of Toronto
🇨🇦Toronto, Ontario, Canada
Starship Children's Hospital
🇳🇿Grafton, Auckland, New Zealand
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Children's National
🇺🇸Washington, District of Columbia, United States
St. Georges, London
🇬🇧London, England, United Kingdom
University of Louisville
🇺🇸Louisville, Kentucky, United States
Oregon Health & Science
🇺🇸Portland, Oregon, United States
Royal Brompton Hospital
🇬🇧London, England, United Kingdom