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Completed

NCT Number: NCT02549664

Exercise in Genetic Cardiovascular Conditions

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

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Long QT Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital/Sydney AU, Camperdown, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: LIVE-HCM/LQT

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Sep 15, 2015
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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