Exercise in Genetic Cardiovascular Conditions

Hypertrophic Cardiomyopathy Clinical Trial

— LIVE-HCM/LQT  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549664
• Other study ID #: 1411014982
• Secondary ID: 1R01HL125918-01
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: November 14, 2022

Study information

• Verified date: September 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Ancillary study Aim: To understand how the coronavirus epidemic is impacting psychological health and quality of life in the LIVE population

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.

The Ancillary study is optional. This will include all of the baseline questionnaires,as well as selected questions from the Epi-Pandemic Impacts Inventory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4299
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Long QT Syndrome
• Syndrome

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital/Sydney AU	Camperdown	New South Wales
Canada	University of Toronto	Toronto	Ontario
Canada	University of BC, Children's	Vancouver	British Columbia
Canada	University of BC, Providence Health	Vancouver	British Columbia
New Zealand	Starship Children's Hospital	Grafton	Auckland
United Kingdom	Royal Brompton Hospital	London	England
United Kingdom	St. Georges, London	London	England
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins	Baltimore	Maryland
United States	Boston Children's	Boston	Massachusetts
United States	Brigham & Women's	Boston	Massachusetts
United States	Tufts	Boston	Massachusetts
United States	Lurie Children's	Chicago	Illinois
United States	Cincinnati Children's	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Texas Children's	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Louisville	Louisville	Kentucky
United States	Miami Children's (Nicklaus Children's Hospital)	Miami	Florida
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	NYU	New York	New York
United States	Children's Omaha	Omaha	Nebraska
United States	University of California Irvine	Orange	California
United States	Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Science	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah (Primary Children's)	Salt Lake City	Utah
United States	University of California, San Diego (Rady's Children's Hospital)	San Diego	California
United States	Seattle Children's	Seattle	Washington
United States	Stanford	Stanford	California
United States	University of Arizona	Tucson	Arizona
United States	Children's National	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epi-Pandemic Impacts Inventory (select questions)	Will assess COVID 19 infection in themselves/family/friends, and impact on jobs and financial status.	4 months
Primary	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	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
Secondary	Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL)	Will assess using Pediatric Quality of Life Inventory (PedsQL)	Five Years
Secondary	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