Cardiomyopathy, HypertrophicNCT01165749
Exercise Study Including Patients With Hypertrophic Cardiomyopathy
An observational study of Cardiomyopathy, Hypertrophic, run by Stanford University at 1 site in United States.
Trial summary
The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Hypertrophic
- What is being tested?
- stop exercising
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Apr 2012
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients diagnosed with hypertrophic cardiomyopathy
Who may be able to join
- Ages 18 - 80 years old.
- Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) > 13 mm in any wall segment.
- Exercise £ 30 minutes, 1 day per week for the previous 3 months.
- Agreement to be a participant in the study protocol and willing/able to return for follow-up.
Who cannot join
- History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
- Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy.
- Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
- Hypotensive response to exercise (> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
- Pregnancy.
- ICD placement in last 3 months or scheduled.
- Life expectancy less than 12 months.
- Inability to exercise due to orthopedic or other non-cardiovascular limitations.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Lisa Garrett, 650-736-7878, lisamariegarrett@gmail.com
Terra Coakley, (650) 725-6186, tcoakley@stanford.edu
About this study
Official title: A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy
The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.
- Conditions
- Cardiomyopathy, Hypertrophic
- Being tested
- stop exercising
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stop exercisingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ability to perform activities and tasks.
Measured: 4 months
Secondary outcomes (1)
Improvement in heart size and function and quality of life (QOL).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, HypertrophicStudies of the same condition, open and under way.
- More trials run by Stanford 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Investigators
- Dr. Euan Ashley MRCP, DPhil, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165749
- Sponsor's protocol ID
- SU-05062010-5902
- Other IDs
- 18518
- Status last verified
- Jul 2010
- First submitted
- 16 Jul 2010
- Last updated
- 20 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01165749
- Acronym / sponsor ID
- SU-05062010-5902
- Conditions
- Cardiomyopathy, Hypertrophic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- May 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 20 Jul 2010 (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 long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with hypertrophic cardiomyopathy
Key inclusion criteria (4 listed)
- Ages 18 - 80 years old.
- Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) > 13 mm in any wall segment.
- Exercise £ 30 minutes, 1 day per week for the previous 3 months.
- Agreement to be a participant in the study protocol and willing/able to return for follow-up.
Key exclusion criteria (8 listed)
- History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
- Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy.
- Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
- Hypotensive response to exercise (> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stop exercising | Behavioural | – |
Primary outcome
Improvement in ability to perform activities and tasks.
Time frame: 4 months
1 secondary outcome
Improvement in heart size and function and quality of life (QOL).
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
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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.
Dr. Euan Ashley MRCP, DPhil principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Hypertrophic, run by Stanford University at 1 site in United States.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Garrett ((650) 736-7878, lisamariegarrett@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in ability to perform activities and tasks. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2010; AzTrials last refreshed its copy on 29 Oct 2026.