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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

Tracking Information
First Submitted Date June 10, 2015
First Posted Date September 15, 2015
Last Update Posted Date April 26, 2019
Study Start Date May 2015
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2015)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02549664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 14, 2015)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exercise in Genetic Cardiovascular Conditions
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"
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).
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome between the ages of 8-60.
Condition
  • Hypertrophic Cardiomyopathy
  • Long QT Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • LQT/HCM sedentary patients
    LQT/HCM sedentary lifestyle
  • LQT/HCM moderate/vigorous exercise
    LQT/HCM participate in moderate or vigorous exercise
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 25, 2019)
4299
Original Estimated Enrollment
 (submitted: September 14, 2015)
4286
Estimated Study Completion Date December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   New Zealand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02549664
Other Study ID Numbers 1411014982
1R01HL125918-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yale University
Study Sponsor Yale University
Collaborators
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Rachel Lampert, MD Yale University
PRS Account Yale University
Verification Date April 2019