Exercise in Genetic Cardiovascular Conditions (LIVE-HCM/LQT)

Exercise in Genetic Cardiovascular Conditions (Lifestyle and Exercise in Hypertrophic Cardiomyopathy "LIVE-HCM"/Lifestyle and Exercise in the Long QT Syndrome "LIVE-LQTS"

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

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy; Long QT Syndrome

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 Type: Observational
• Enrollment (Actual): 4299

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, NSW 2050
      • Royal Prince Alfred Hospital/Sydney AU
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6E 1M7
      • University of BC, Providence Health
    • Vancouver, British Columbia, Canada, V6H 3V4
      • University of BC, Children's
  • Ontario
    • Toronto, Ontario, Canada
      • University of Toronto
• New Zealand
  • Auckland
    • Grafton, Auckland, New Zealand
      • Starship Children's Hospital
• United Kingdom
  • England
    • London, England, United Kingdom, SW3 6NP
      • Royal Brompton Hospital
    • London, England, United Kingdom, SW17 ORE
      • St. Georges, London
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • Orange, California, United States, 92868
      • University of California Irvine
    • San Diego, California, United States, 92123
      • University of California, San Diego (Rady's Children's Hospital)
    • Stanford, California, United States, 94305
      • Stanford
  • Connecticut
    • New Haven, Connecticut, United States, 06420
      • Yale University
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National
  • Florida
    • Miami, Florida, United States, 33155
      • Miami Children's (Nicklaus Children's Hospital)
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's
    • Boston, Massachusetts, United States, 02111
      • Tufts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Children's Omaha
  • New York
    • New York, New York, United States, 10016
      • NYU
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia (CHOP)
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Houston, Texas, United States, 77030
      • Texas Children's
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah (Primary Children's)
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LQT/HCM sedentary patients; LQT/HCM sedentary lifestyle
LQT/HCM moderate/vigorous exercise; LQT/HCM participate in moderate or vigorous exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli)	Will assess using Pediatric Cardiac Quality of Life Inventory (Pcqli)	Five years
Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL)	Will assess using Pediatric Quality of Life Inventory (PedsQL)	Five Years
Physical Quality of Life assessed using Health Status Questionnaire (SF36) Quality of Life for Adults	Will assess using Health Status Questionnaire (SF36) Quality of Life for Adults	Five Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epi-Pandemic Impacts Inventory (select questions)	Will assess COVID 19 infection in themselves/family/friends, and impact on jobs and financial status.	4 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Rachel Lampert, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimated): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hypertrophic Cardiomyopathy (HCM); Long QT Syndrome (LQTS)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Syndrome; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Long QT Syndrome
• Other Study ID Numbers: 1411014982; 1R01HL125918-01 (U.S. NIH Grant/Contract)