Exercise in Genetic Cardiovascular Conditions

NCT02549664 | Completed DMC

• 2 other identifiers: 14110149821R01HL125918-01
• Study Type: observational
• Target: 4,299
• Locations: 5 countries
• Sites: 36

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

Conditions

Hypertrophic Cardiomyopathy; Long QT Syndrome

Keywords

Hypertrophic Cardiomyopathy (HCM); Long QT Syndrome (LQTS)

Outcome Measures

Primary Outcomes (1)

• 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.

  Collect information for death, resuscitated arrest, syncope, appropriate ICD shock , during exercise or at other times, through records from the provider and patient interviews

  Five years

Secondary Outcomes (3)

• Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli)

  Five years

• Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL)

  Five Years

• Physical Quality of Life assessed using Health Status Questionnaire (SF36) Quality of Life for Adults

  Five Years

Other Outcomes (1)

• Epi-Pandemic Impacts Inventory (select questions)

  4 months

Study Arms (2)

LQT/HCM sedentary patients

LQT/HCM sedentary lifestyle

LQT/HCM moderate/vigorous exercise

LQT/HCM participate in moderate or vigorous exercise

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome between the ages of 8-60.

You may qualify if:

• Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (36)

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

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

San Diego, California, 92123, United States

Location

Stanford

Stanford, California, 94305, United States

Location

Yale University

New Haven, Connecticut, 06420, United States

Location

Children's National

Washington D.C., District of Columbia, 20010, United States

Location

Miami Children's (Nicklaus Children's Hospital)

Miami, Florida, 33155, United States

Location

Lurie Children's

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Tufts

Boston, Massachusetts, 02111, United States

Location

Boston Children's

Boston, Massachusetts, 02115, United States

Location

Brigham & Women's

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Children's Omaha

Omaha, Nebraska, 68114, United States

Location

NYU

New York, New York, 10016, United States

Location

Cincinnati Children's

Cincinnati, Ohio, 45229, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Texas Children's

Houston, Texas, 77030, United States

Location

University of Utah (Primary Children's)

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

Royal Prince Alfred Hospital/Sydney AU

Camperdown, New South Wales, NSW 2050, Australia

Location

University of BC, Providence Health

Vancouver, British Columbia, V6E 1M7, Canada

Location

University of BC, Children's

Vancouver, British Columbia, V6H 3V4, Canada

Location

University of Toronto

Toronto, Ontario, Canada

Location

Starship Children's Hospital

Grafton, Auckland, New Zealand

Location

St. Georges, London

London, England, SW17 ORE, United Kingdom

Location

Royal Brompton Hospital

London, England, SW3 6NP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39051104 DERIVED

• 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.

  PMID: 28912187 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Long QT Syndrome

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Lampert, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: September 15, 2015
• Study Start: May 1, 2015
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

GB (2); NZ (1); AU (1); US (29); CA (3)