Hypertrophic CardiomyopathyLIVE-HCM/LQTNCT02549664
Exercise in Genetic Cardiovascular Conditions
An observational study of Hypertrophic Cardiomyopathy and Long QT Syndrome, run by Yale University at 36 sites in 5 countries.
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 Read more about this study
- Who is it for?
- Ages 8 to 60 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Long QT Syndrome
- How many people
- 4,299 participants
- Where
- 36 sitesin 5 countries
- Study dates
- 1 May 2015to 14 Nov 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome between the ages of 8-60.
Who may be able to join
- Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome
Who cannot join
- Individuals with Hypertrophic Cardiomyopathy with systolic or diastolic heart failure which precludes vigorous exercise will not be enrolled (NYHA III/IV)
Trial locations and contacts
36 sites in 5 countries.
36 sites in 5 countries
United States29 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins
Baltimore, Maryland, 21287
Tufts
Boston, Massachusetts, 02111
Boston Children's
Boston, Massachusetts, 02115
Brigham & Women's
Boston, Massachusetts, 02115
Lurie Children's
Chicago, Illinois, 60611
Cincinnati Children's
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwestern
Dallas, Texas, 75390
Texas Children's
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Louisville
Louisville, Kentucky, 40202
Miami Children's (Nicklaus Children's Hospital)
Miami, Florida, 33155
Vanderbilt University
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06420
NYU
New York, New York, 10016
Children's Omaha
Omaha, Nebraska, 68114
University of California Irvine
Orange, California, 92868
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah (Primary Children's)
Salt Lake City, Utah, 84113
University of California, San Diego (Rady's Children's Hospital)
San Diego, California, 92123
Seattle Children's
Seattle, Washington, 98105
Stanford
Stanford, California, 94305
University of Arizona
Tucson, Arizona, 85724
Children's National
Washington D.C., District of Columbia, 20010
Canada3 sites
University of Toronto
Toronto, Ontario
University of BC, Providence Health
Vancouver, British Columbia, V6E 1M7
University of BC, Children's
Vancouver, British Columbia, V6H 3V4
United Kingdom2 sites
St. Georges, London
London, England, SW17 ORE
Royal Brompton Hospital
London, England, SW3 6NP
Australia1 site
Royal Prince Alfred Hospital/Sydney AU
Camperdown, New South Wales, NSW 2050
About this study
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"
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
Read the 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.
- Conditions
- Hypertrophic Cardiomyopathy, Long QT Syndrome
- Keywords
- Hypertrophic Cardiomyopathy (HCM), Long QT Syndrome (LQTS)
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LQT/HCM sedentary patients | LQT/HCM sedentary lifestyle | |
| LQT/HCM moderate/vigorous exercise | LQT/HCM participate in moderate or vigorous exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Five years
Secondary outcomes (3)
Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli)
Will assess using Pediatric Cardiac Quality of Life Inventory (Pcqli)
Measured: Five years
Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL)
Will assess using Pediatric Quality of Life Inventory (PedsQL)
Measured: Five Years
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
Measured: Five Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start1 May 2015
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,299 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Rachel Lampert, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549664
- Sponsor's protocol ID
- 1411014982
- Other IDs
- 1R01HL125918-01
- Acronym
- LIVE-HCM/LQT
- Status last verified
- Sep 2023
- First submitted
- 10 Jun 2015
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lampert R, Day S, Ainsworth B, Burg M, Marino BS, Salberg L, Tome Esteban MT, Abrams DJ, Aziz PF, Barth C, Behr ER, Bell C, Berul CI, Bos JM, Bradley D, Cannom DS, Cannon BC, Concannon MA, Cerrone M, Czosek RJ, Dubin AM, Dziura J, Erickson CC, Estes NAM 3rd, Etheridge SP, Goldenberg I, Gray B, Haglund-Turnquist C, Harmon K, James CA, Johnsrude C, Kannankeril P, Lara A, Law IH, Li F, Link MS, Molossi SM, Olshansky B, Noseworthy PA, Saarel EV, Sanatani S, Shah M, Simone L, Skinner J, Tomaselli GF, Ware JS, Webster G, Zareba W, Zipes DP, Ackerman MJ. Vigorous Exercise in Patients With Congenital Long QT Syndrome: Results of the Prospective, Observational, Multinational LIVE-LQTS Study. Circulation. 2024 Aug 13;150(7):516-530. doi: 10.1161/CIRCULATIONAHA.123.067590. Epub 2024 Jul 25.
PubMed 39051104Lee 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.
PubMed 28912187
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT02549664
- Acronym / sponsor ID
- LIVE-HCM/LQT / 1411014982
- Conditions
- Hypertrophic Cardiomyopathy, Long QT Syndrome
- Keywords
- Hypertrophic Cardiomyopathy (HCM), Long QT Syndrome (LQTS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,299 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 May 2015 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LQT/HCM sedentary patients | – | –LQT/HCM sedentary lifestyle |
| LQT/HCM moderate/vigorous exercise | – | –LQT/HCM participate in moderate or vigorous exercise |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome between the ages of 8-60.
Key inclusion criteria (1 listed)
- Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome
Key exclusion criteria (1 listed)
- Individuals with Hypertrophic Cardiomyopathy with systolic or diastolic heart failure which precludes vigorous exercise will not be enrolled (NYHA III/IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Emotional Quality of Life assessed using Pediatric Cardiac Quality of Life Inventory (Pcqli)
Time frame: Five years
Physical Quality of Life assessed using Pediatric Quality of Life Inventory (PedsQL)
Time frame: Five Years
Physical Quality of Life assessed using Health Status Questionnaire (SF36) Quality of Life for Adults
Time frame: Five Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 39051104Lampert R, Day S, Ainsworth B, Burg M, Marino BS, Salberg L, Tome Esteban MT, Abrams DJ, Aziz PF, Barth C, Behr ER, Bell C, Berul CI, Bos JM, Bradley D, Cannom DS, Cannon BC, Concannon MA, Cerrone M, Czosek RJ, Dubin AM, Dziura J, Erickson CC, Estes NAM 3rd, Etheridge SP, Goldenberg I, Gray B, Haglund-Turnquist C, Harmon K, James CA, Johnsrude C, Kannankeril P, Lara A, Law IH, Li F, Link MS, Molossi SM, Olshansky B, Noseworthy PA, Saarel EV, Sanatani S, Shah M, Simone L, Skinner J, Tomaselli GF, Ware JS, Webster G, Zareba W, Zipes DP, Ackerman MJ. Vigorous Exercise in Patients With Congenital Long QT Syndrome: Results of the Prospective, Observational, Multinational LIVE-LQTS Study. Circulation. 2024 Aug 13;150(7):516-530. doi: 10.1161/CIRCULATIONAHA.123.067590. Epub 2024 Jul 25.
- Derived from this study: PubMed 28912187Lee 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.
- The goal of the Lifestyle and Exercise in Hypertrophic Cardiomyopathy Study (LIVE-HCM) is to determine how lifestyle and exercise impact the well-being of individuals with HCMLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Lampert, MD principal investigator
Yale University
36 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy and Long QT Syndrome, run by Yale University at 36 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada, United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549664, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.