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

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ClinicalTrials.gov Identifier: NCT02549664
Recruitment Status : Active, not recruiting
First Posted : September 15, 2015
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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).

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 4299 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Exercise in Genetic Cardiovascular Conditions (Lifestyle and Exercise in Hypertrophic Cardiomyopathy "LIVE-HCM"/Lifestyle and Exercise in the Long QT Syndrome "LIVE-LQTS"
Study Start Date : May 2015
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021


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



Primary Outcome Measures :
  1. 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. [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli) [ Time Frame: Five years ]
    Will assess using Pediatric Cardiac Quality of Life Inventory (Pcqli)

  2. Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Five Years ]
    Will assess using Pediatric Quality of Life Inventory (PedsQL)

  3. Physical Quality of Life assessed using Health Status Questionnaire (SF36) Quality of Life for Adults [ Time Frame: Five Years ]
    Will assess using Health Status Questionnaire (SF36) Quality of Life for Adults



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549664


  Hide Study Locations
Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Cedar Sinai/LA Cardiology
Los Angeles, California, United States, 90017
University of California Irvine
Orange, California, United States, 92868
University of California, San Diego (Rady's Children's Hospital)
San Diego, California, United States, 92123
Stanford
Stanford, California, United States, 94305
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06420
United States, District of Columbia
Children's National
Washington, District of Columbia, United States, 20010
United States, Florida
Miami Children's (Nicklaus Children's Hospital)
Miami, Florida, United States, 33155
United States, Illinois
Lurie Children's
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Tufts
Boston, Massachusetts, United States, 02111
Boston Children's
Boston, Massachusetts, United States, 02115
Brigham & Women's
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
Children's Omaha
Omaha, Nebraska, United States, 68114
United States, New York
NYU
New York, New York, United States, 10016
United States, Ohio
Cincinnati Children's
Cincinnati, Ohio, United States, 45229
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science
Portland, Oregon, United States, 97239
United States, Pennsylvania
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
University of Tennessee Health Science Center/Le Bonheur
Memphis, Tennessee, United States, 38103
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Texas Children's
Houston, Texas, United States, 77030
United States, Utah
University of Utah (Primary Children's)
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Children's
Seattle, Washington, United States, 98105
University of Washington
Seattle, Washington, United States, 98195
Australia, New South Wales
Royal Prince Alfred Hospital/Sydney AU
Camperdown, New South Wales, Australia, NSW 2050
Canada, British Columbia
University of BC, Providence Health
Vancouver, British Columbia, Canada, V6E 1M7
University of BC, Children's
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada
New Zealand
Starship Children's Hospital
Grafton, Auckland, New Zealand
United Kingdom
St. Georges, London
London, England, United Kingdom, SW17 ORE
Royal Brompton Hospital
London, England, United Kingdom, SW3 6NP
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Rachel Lampert, MD Yale University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02549664     History of Changes
Other Study ID Numbers: 1411014982
1R01HL125918-01 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Keywords provided by Yale University:
Hypertrophic Cardiomyopathy (HCM)
Long QT Syndrome (LQTS)
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Long QT Syndrome
Syndrome
Hypertrophy
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities