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

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ClinicalTrials.gov Identifier: NCT02549664
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : October 18, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University

June 10, 2015
September 15, 2015
October 18, 2017
May 2015
May 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02549664 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • 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
Same as current
Not Provided
Not Provided
 
Exercise in Genetic Cardiovascular Conditions
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).
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.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
3 Years
Not Provided
Non-Probability Sample
Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome between the ages of 8-60.
  • Hypertrophic Cardiomyopathy
  • Long QT Syndrome
Not Provided
  • LQT/HCM sedentary patients
    LQT/HCM sedentary lifestyle
  • LQT/HCM moderate/vigorous exercise
    LQT/HCM participate in moderate or vigorous exercise
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4286
Same as current
May 2020
May 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
8 Years to 60 Years   (Child, Adult)
No
Contact: Theresa Donovan, BS 866-207-9813 theresa.donovan@yale.edu
Contact: Cheryl Barth, BS 203-737-1079 cheryl.barth@yale.edu
Australia,   Canada,   New Zealand,   United Kingdom,   United States
 
 
NCT02549664
1411014982
1R01HL125918-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Yale University
Yale University
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Rachel Lampert, MD Yale University
Yale University
December 2016