Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02549664




Registration number
NCT02549664
Ethics application status
Date submitted
10/06/2015
Date registered
15/09/2015
Date last updated
5/09/2023

Titles & IDs
Public title
Exercise in Genetic Cardiovascular Conditions
Scientific title
Exercise in Genetic Cardiovascular Conditions (Lifestyle and Exercise in Hypertrophic Cardiomyopathy "LIVE-HCM"/Lifestyle and Exercise in the Long QT Syndrome "LIVE-LQTS"
Secondary ID [1] 0 0
1R01HL125918-01
Secondary ID [2] 0 0
1411014982
Universal Trial Number (UTN)
Trial acronym
LIVE-HCM/LQT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic Cardiomyopathy 0 0
Long QT Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
LQT/HCM sedentary patients - LQT/HCM sedentary lifestyle

LQT/HCM moderate/vigorous exercise - LQT/HCM participate in moderate or vigorous exercise
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Five years
Secondary outcome [1] 0 0
Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli)
Timepoint [1] 0 0
Five years
Secondary outcome [2] 0 0
Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL)
Timepoint [2] 0 0
Five Years
Secondary outcome [3] 0 0
Physical Quality of Life assessed using Health Status Questionnaire (SF36) Quality of Life for Adults
Timepoint [3] 0 0
Five Years

Eligibility
Key inclusion criteria
* Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome
Minimum age
8 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Individuals with Hypertrophic Cardiomyopathy with systolic or diastolic heart failure which precludes vigorous exercise will not be enrolled (NYHA III/IV)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/11/2022
Sample size
Target
Accrual to date
Final
4299
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital/Sydney AU - Camperdown
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
United Kingdom
State/province [26] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
Yale University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institutes of Health (NIH)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel Lampert, MD
Address 0 0
Yale University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02549664