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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02549664
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : October 18, 2017
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]
Estimated Enrollment : 4286 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 : May 2018
Estimated Study Completion Date : May 2020

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.

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 identifier (NCT number): NCT02549664

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Contact: Theresa Donovan, BS 866-207-9813
Contact: Cheryl Barth, BS 203-737-1079

  Hide Study Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Lizette Marquez, BS    520-626-5431   
Principal Investigator: Jil Tardif, MD         
United States, California
Cedar Sinai/LA Cardiology Not yet recruiting
Los Angeles, California, United States, 90017
Contact: Young Park, RN    213-977-4176   
Principal Investigator: David Cannom, MD         
University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Ofelia Vargas-Shiraishi, BS CCRC    714-509-8735   
Principal Investigator: Anjan Batra, MD         
University of California, San Diego (Rady's Children's Hospital) Recruiting
San Diego, California, United States, 92123
Contact: Robyn Jucius, BS    858-576-1700 ext 7139   
Principal Investigator: James Perry, MD         
Stanford Recruiting
Stanford, California, United States, 94305
Contact: Spencer Chen, BS    650-736-6982   
Principal Investigator: Euan Ashley, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06420
Contact: Theresa Donovan, BS    866-207-9813   
Contact: Cheryl Barth, BS    203-737-1079   
Principal Investigator: Rachel Lampert, MD         
United States, District of Columbia
Children's National Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Sridhar Hanuamanthaiah, BS    202-476-4970      
Principal Investigator: Charles Berul, MD         
United States, Florida
Miami Children's (Nicklaus Children's Hospital) Recruiting
Miami, Florida, United States, 33155
Contact: Anabel Rodriguez, BS    786-624-2590   
Principal Investigator: Ronald Kanter, MD         
United States, Illinois
Lurie Children's Recruiting
Chicago, Illinois, United States, 60611
Contact: Kathleen Van't Hof, BS    312-227-1549   
Principal Investigator: Greg Webster, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Janice Folkening-Walker, BS    317-274-0985   
Principal Investigator: Michael Emery, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jennifer Lampe, BS    319-356-3537   
Principal Investigator: Ian Law, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Sarah Penny, BS    502-629-2721   
Principal Investigator: Janice sullivan, MD         
Principal Investigator: Christopher Johnsrude, MD         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Becky McClellan, BS    410-502-2578   
Principal Investigator: Gordon Tomaselli, MD         
United States, Massachusetts
Tufts Recruiting
Boston, Massachusetts, United States, 02111
Contact: Melanie Marshall    617-636-5000   
Principal Investigator: Martin Maron, MD         
Boston Children's Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jane Messere, BS    857-218-3628   
Principal Investigator: Steve Colan, MD         
Brigham & Women's Recruiting
Boston, Massachusetts, United States, 02115
Contact: Stephanie Harris, BS    617-525-7168   
Principal Investigator: Carolyn Ho, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Matt Kolevar   
Principal Investigator: Sharlene Day, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carla Haglund-turnquist    507-284-8900   
Principal Investigator: Michael J. Ackerman, M.D., Ph.D.         
United States, Nebraska
Children's Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: LuAnn Mill, BS    402-955-4350   
Principal Investigator: Christopher Erickson, MD         
United States, New York
NYU Recruiting
New York, New York, United States, 10016
Contact: Marina Cerrone, MD    212-263-9136   
Principal Investigator: Marina Cerrone, MD         
United States, Ohio
Cincinnati Children's Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Paula Casson, BA, CCRP    513-803-9003   
Principal Investigator: Richard Coszek, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Lauren Sabolik, BS    216-444-7932   
Principal Investigator: Peter F Aziz, MD, FHRS         
United States, Oregon
Oregon Health & Science Recruiting
Portland, Oregon, United States, 97239
Contact: Meghan Chirpich, BS    503-494-1775   
Principal Investigator: Stephen Heitner, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia (CHOP) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tiana Butler    267-426-9820   
Principal Investigator: Mually Shah, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kathy Puntil, RN    412-647-3611   
Principal Investigator: Timothy Wong, MD         
United States, Tennessee
University of Tennessee Health Science Center/Le Bonheur Recruiting
Memphis, Tennessee, United States, 38103
Contact: Jeffrey Towbin, MD    901-287-6380   
Principal Investigator: Jeffrey Towbin, MD         
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Darlene Fountain, RN, BSN    615-343-6503   
Principal Investigator: Prince Kannankeril, MD         
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Anne Leyretana-Zabat, BS    214-645-7083   
Principal Investigator: Aslan Turer, MD         
Texas Children's Recruiting
Houston, Texas, United States, 77030
Contact: Melissa Challman, BS   
Principal Investigator: Silvana Molossi, MD         
United States, Utah
University of Utah (Primary Children's) Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Amy Butler, BS    801-587-9011   
Principal Investigator: Susan Etheridge, MD         
United States, Washington
Seattle Children's Recruiting
Seattle, Washington, United States, 98105
Contact: Abigail Majercik, BS    206-987-7173   
Principal Investigator: Jack Salerno, MD         
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: David Owens, MD    206-221-7594   
Principal Investigator: David Owens, MD         
Australia, New South Wales
Royal Prince Alfred Hospital/Sydney AU Recruiting
Camperdown, New South Wales, Australia, NSW 2050
Contact: Christopher Semsarian, MD    +61 2 9565 6195   
Principal Investigator: Christopher Semsarian, MD         
Canada, British Columbia
University of BC, Providence Health Recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Contact: Karen Gibbs, BS    604-682-2344 ext 63260   
Principal Investigator: Andrew Krahn, MD         
University of BC, Children's Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Sonia Franciosi, BS    604-875-3619   
Principal Investigator: Subhayan Sanatini, MD         
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada
Contact: Sharmil Udupa, BS   
Principal Investigator: Michael Gollob, MD         
New Zealand
Starship Children's Hospital Recruiting
Grafton, Auckland, New Zealand
Contact: Jon Skinner, MBChB, MD    (09) 307 4949   
Principal Investigator: Jon Skinner, MBChB, MD         
United Kingdom
St. Georges, London Recruiting
London, England, United Kingdom, SW17 ORE
Contact: Maria Esteban, MD    020-3456-4801   
Principal Investigator: Maria Esteban, MD         
Royal Brompton Hospital Not yet recruiting
London, England, United Kingdom, SW3 6NP
Contact: James Ware, MD    +44 (0)20 7352 8121   
Principal Investigator: James Ware, MD         
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Rachel Lampert, MD Yale University

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yale University 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: October 18, 2017
Last Verified: December 2016

Keywords provided by Yale University:
Hypertrophic Cardiomyopathy (HCM)
Long QT Syndrome (LQTS)

Additional relevant MeSH terms:
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Cardiomyopathy, Hypertrophic
Long QT Syndrome
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