Exercise in Genetic Cardiovascular Conditions

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Exercise in Genetic Cardiovascular Conditions (Lifestyle and Exercise in Hypertrophic Cardiomyopathy LIVE-HCM/Lifestyle and Exercise in the Long QT Syndrome LIVE-LQTS

Conditions
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Hypertrophic Cardiomyopathy, Long QT Syndrome

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LQT/HCM sedentary patients<br>LQT/HCM sedentary lifestyle | |
| LQT/HCM moderate/vigorous exercise<br>LQT/HCM participate in moderate or vigorous exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Collect information for death, resuscitated arrest, syncope, appropriate ICD shock , during exercise or at other times, through records from the provider and patient interviews | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli) | Will assess using Pediatric Cardiac Quality of Life Inventory (Pcqli) | Five years | 
| Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL) | Will assess using Pediatric Quality of Life Inventory (PedsQL) | Five Years | 
| Physical Quality of Life assessed using Health Status Questionnaire (SF36) Quality of Life for Adults | Will assess using Health Status Questionnaire (SF36) Quality of Life for Adults | Five Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertrophic Cardiomyopathy (HCM), Long QT Syndrome (LQTS)