Exercise in Genetic Cardiovascular Conditions

NCT ID: NCT02549664

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4299 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2022-11-14

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.

Conditions

Hypertrophic Cardiomyopathy; Long QT Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

LQT/HCM sedentary patients

LQT/HCM sedentary lifestyle

No interventions assigned to this group

LQT/HCM moderate/vigorous exercise

LQT/HCM participate in moderate or vigorous exercise

No interventions assigned to this group

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Lampert, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

University of Arizona

Tucson, Arizona, United States

University of California Irvine

Orange, California, United States

University of California, San Diego (Rady's Children's Hospital)

San Diego, California, United States

Stanford

Stanford, California, United States

Yale University

New Haven, Connecticut, United States

Children's National

Washington D.C., District of Columbia, United States

Miami Children's (Nicklaus Children's Hospital)

Miami, Florida, United States

Lurie Children's

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Louisville

Louisville, Kentucky, United States

Johns Hopkins

Baltimore, Maryland, United States

Tufts

Boston, Massachusetts, United States

Boston Children's

Boston, Massachusetts, United States

Brigham & Women's

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Children's Omaha

Omaha, Nebraska, United States

NYU

New York, New York, United States

Cincinnati Children's

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health & Science

Portland, Oregon, United States

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

UT Southwestern

Dallas, Texas, United States

Texas Children's

Houston, Texas, United States

University of Utah (Primary Children's)

Salt Lake City, Utah, United States

Seattle Children's

Seattle, Washington, 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

St. Georges, London

London, England, United Kingdom

Royal Brompton Hospital

London, England, United Kingdom

Countries

United States; Australia; Canada; New Zealand; United Kingdom

References

Lampert R, Day S, Ainsworth B, Burg M, Marino BS, Salberg L, Tome Esteban MT, Abrams DJ, Aziz PF, Barth C, Behr ER, Bell C, Berul CI, Bos JM, Bradley D, Cannom DS, Cannon BC, Concannon MA, Cerrone M, Czosek RJ, Dubin AM, Dziura J, Erickson CC, Estes NAM 3rd, Etheridge SP, Goldenberg I, Gray B, Haglund-Turnquist C, Harmon K, James CA, Johnsrude C, Kannankeril P, Lara A, Law IH, Li F, Link MS, Molossi SM, Olshansky B, Noseworthy PA, Saarel EV, Sanatani S, Shah M, Simone L, Skinner J, Tomaselli GF, Ware JS, Webster G, Zareba W, Zipes DP, Ackerman MJ. Vigorous Exercise in Patients With Congenital Long QT Syndrome: Results of the Prospective, Observational, Multinational LIVE-LQTS Study. Circulation. 2024 Aug 13;150(7):516-530. doi: 10.1161/CIRCULATIONAHA.123.067590. Epub 2024 Jul 25.

Reference Type: DERIVED

PMID: 39051104 (View on PubMed)

Lee TM, Hsu DT, Kantor P, Towbin JA, Ware SM, Colan SD, Chung WK, Jefferies JL, Rossano JW, Castleberry CD, Addonizio LJ, Lal AK, Lamour JM, Miller EM, Thrush PT, Czachor JD, Razoky H, Hill A, Lipshultz SE. Pediatric Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):855-873. doi: 10.1161/CIRCRESAHA.116.309386.

Reference Type: DERIVED

PMID: 28912187 (View on PubMed)

Other Identifiers

1R01HL125918-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1411014982

Identifier Type: -

Identifier Source: org_study_id