Clinical trial NCT02549664: Exercise in Genetic Cardiovascular Conditions
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Long QT Syndrome
Keywords: Hypertrophic Cardiomyopathy (HCM)
Long QT Syndrome (LQTS)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-09-15
Enrollment: 4299
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome between the ages of 8-60.

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).

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

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.

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

Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: Five years
Secondary outcomes:
measure: Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli)
timeFrame: Five years
measure: Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Five Years
measure: Physical Quality of Life assessed using Health Status Questionnaire (SF36) Quality of Life for Adults
timeFrame: Five Years
Other outcomes:
measure: Epi-Pandemic Impacts Inventory (select questions)
timeFrame: 4 months
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Orange
country: United States
facility: University of California Irvine
state: California
city: San Diego
country: United States
facility: University of California, San Diego (Rady's Children's Hospital)
state: California
city: Stanford
country: United States
facility: Stanford
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Children's National
state: District of Columbia
city: Miami
country: United States
facility: Miami Children's (Nicklaus Children's Hospital)
state: Florida
city: Chicago
country: United States
facility: Lurie Children's
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Tufts
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: Children's Omaha
state: Nebraska
city: New York
country: United States
facility: NYU
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia (CHOP)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Texas Children's
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah (Primary Children's)
state: Utah
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital/Sydney AU
state: New South Wales
city: Vancouver
country: Canada
facility: University of BC, Providence Health
state: British Columbia
city: Vancouver
country: Canada
facility: University of BC, Children's
state: British Columbia
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Grafton
country: New Zealand
facility: Starship Children's Hospital
state: Auckland
city: London
country: United Kingdom
facility: St. Georges, London
state: England
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: England
Study officials:
affiliation: Yale University
name: Rachel Lampert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee TM, Hsu DT, Kantor P, Towbin JA, Ware SM, Colan SD, Chung WK, Jefferies JL, Rossano JW, Castleberry CD, Addonizio LJ, Lal AK, Lamour JM, Miller EM, Thrush PT, Czachor JD, Razoky H, Hill A, Lipshultz SE. Pediatric Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):855-873. doi: 10.1161/CIRCRESAHA.116.309386.