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 : February 2, 2021
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
|Condition or disease|
|Hypertrophic Cardiomyopathy Long QT Syndrome|
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 [Patient Registry]|
|Actual Enrollment :||4299 participants|
|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|
LQT/HCM sedentary patients
LQT/HCM sedentary lifestyle
LQT/HCM moderate/vigorous exercise
LQT/HCM participate in moderate or vigorous exercise
- 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. [ Time Frame: Five years ]Collect information for death, resuscitated arrest, syncope, appropriate ICD shock , during exercise or at other times, through records from the provider and patient interviews
- 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
- Epi-Pandemic Impacts Inventory (select questions) [ Time Frame: 4 months ]Will assess COVID 19 infection in themselves/family/friends, and impact on jobs and financial status.
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
|Principal Investigator:||Rachel Lampert, MD||Yale University|