Hypertrophic CardiomyopathyEXCITE-HCMNCT05818605
Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy
A study testing Moderate Intensity Exercise Program in people with Hypertrophic Cardiomyopathy, run by University of California, San Francisco at 1 site in United States.
Trial summary
The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Moderate Intensity Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
- Left ventricular outflow tract gradient <30 mmHg at rest and with provocation.
- Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
- Access to exercise equipment at home or at a fitness center.
- Ability to complete study related testing including online surveys and smart phone use
- Ability to perform 24 weeks of exercise training
Who cannot join
- History of exercise-induced syncope or ventricular arrhythmias
- LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
- History of septal reduction therapy - surgery or ablation
- History of ICD placement in the previous 3 months
- History of hypotensive response with exercise testing (>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure >20 mm Hg)
- Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian Cardiovascular Society class IV angina symptoms
Show all 11Show fewer
- Left ventricular ejection fraction less than 50% by echocardiography
- Life expectancy less than 12 months
- Pregnant or planned pregnancy
- Inability to exercise owing to any medical or other limitations
- Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California - San Francisco
San Francisco, California, 94143
Cynthia Partida-Higuera, CCRP, 415-514-1125, Cynthia.Partida-Higuera@ucsf.edu
Theodore P Abraham, M.D
About this study
Official title: The EXerCise traIning To rEcovery in HCM Trial
The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Moderate Intensity Exercise Program
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Exercise ProgramBehavioural
Subjects randomized to the EXER arm will undergo 24 weeks of Moderate Intensity Exercise Training (MIET). Patients will be signed up for 60-minute exercise sessions, 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Exercise arm | Experimental | All patients randomized to the exercise training group will undergo a single supervised in-hospital exercise session that includes an exercise consultation with a certified exercise physiologist. Following that they will exercise at-home with video supervision 3 times a week for a period of 24 weeks. Receives: Behavioral: Moderate Intensity Exercise Program |
| Usual physical activity arm | No intervention | Patients randomized to the usual-activity group will be instructed to continue their current activity without initiating or intensifying any existing exercise regimens for the duration of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in V O2 max
Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET
Measured: Baseline and 24 weeks
Change in peak VO2 %
Change in peak VO2 % predicted (%) by CPET
Measured: Baseline and 24 weeks
Secondary outcomes (2)
Change in Myocardial Systolic Strain
Change in Myocardial systolic strain (%) by echocardiography
Measured: Baseline and 24 Weeks
Change in Myocardial Work
Change Myocardial work (mmHg%) by echocardiography
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start17 Feb 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, blinded
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Theodore P Abraham, M.D, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818605
- Sponsor's protocol ID
- R01HL157238
- Other IDs
- R01HL157238
- Acronym
- EXCITE-HCM
- Status last verified
- Nov 2025
- First submitted
- 5 Apr 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXerCise traIning To rEcovery in HCM Trial
- ClinicalTrials.gov ID
- NCT05818605
- Acronym / sponsor ID
- EXCITE-HCM / R01HL157238
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Apr 2023 (actual)
- 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 EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled, blinded
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Exercise arm | Experimental | Behavioral: Moderate Intensity Exercise ProgramAll patients randomized to the exercise training group will undergo a single supervised in-hospital exercise session that includes an exercise consultation with a certified exercise physiologist. Following that they will exercise at-home with video supervision 3 times a week for a period of 24 weeks. |
| Usual physical activity arm | No intervention | –Patients randomized to the usual-activity group will be instructed to continue their current activity without initiating or intensifying any existing exercise regimens for the duration of the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
- Left ventricular outflow tract gradient <30 mmHg at rest and with provocation.
- Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
- Access to exercise equipment at home or at a fitness center.
- Ability to complete study related testing including online surveys and smart phone use
Key exclusion criteria (11 listed)
- History of exercise-induced syncope or ventricular arrhythmias
- LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
- History of septal reduction therapy - surgery or ablation
- History of ICD placement in the previous 3 months
- History of hypotensive response with exercise testing (>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure >20 mm Hg)
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 |
|---|---|---|
| Moderate Intensity Exercise ProgramSubjects randomized to the EXER arm will undergo 24 weeks of Moderate Intensity Exercise Training (MIET). Patients will be signed up for 60-minute exercise sessions, 3 times a week | Behavioural | Moderate Intensity Exercise arm |
Primary outcome
Change in V O2 max
Time frame: Baseline and 24 weeks
Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET
Change in peak VO2 %
Time frame: Baseline and 24 weeks
Change in peak VO2 % predicted (%) by CPET
2 secondary outcomes
Change in Myocardial Systolic Strain
Time frame: Baseline and 24 Weeks
Change in Myocardial Work
Time frame: Baseline and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Theodore P Abraham, M.D principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Exercise Program in people with Hypertrophic Cardiomyopathy, run by University of California, San Francisco 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Partida-Higuera, CCRP (415-514-1125, Cynthia.Partida-Higuera@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in V O2 max (time frame: Baseline and 24 weeks). The study lists 2 primary outcomes in all. 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 Nov 2025.