Exercise in Genetic Cardiovascular Conditions

Completed

• Conditions: Hypertrophic Cardiomyopathy; Long 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.

Study Timeline

• Study Start: 2015-05-01
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4299

Inclusion Criteria

• Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome

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Exclusion Criteria

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

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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