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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

Study Description
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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).

Condition or disease
Hypertrophic Cardiomyopathy Long QT Syndrome

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4286 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : May 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
LQT/HCM sedentary patients
LQT/HCM sedentary lifestyle
LQT/HCM moderate/vigorous exercise
LQT/HCM participate in moderate or vigorous exercise


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome between the ages of 8-60.
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Theresa Donovan, BS 866-207-9813 theresa.donovan@yale.edu
Contact: Cheryl Barth, BS 203-737-1079 cheryl.barth@yale.edu

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Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Rachel Lampert, MD Yale University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02549664     History of Changes
Other Study ID Numbers: 1411014982
1R01HL125918-01 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: December 2016

Keywords provided by Yale University:
Hypertrophic Cardiomyopathy (HCM)
Long QT Syndrome (LQTS)

Additional relevant MeSH terms:
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Syndrome
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Long QT Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities