Hypertrophic Cardiomyopathy (HCM)NCT07054073
HCMR Re-Imaging Study
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Christopher Kramer at 8 sites in 2 countries.
Trial summary
This study aims to learn what might predict heart problems (like sudden death from a fast heart rhythm or heart failure) in people with a genetic condition called hypertrophic cardiomyopathy (HCM). HCM causes the heart muscle to become thick, which can make the heart stiff and harder to work properly. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- What is being tested?
- None - observational study
- How many people
- 314 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 27 Jul 2026to Jul 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants from the HCMR original cohort who also meet this study's eligibility criteria.
Who may be able to join
- Patients in the original HCMR cohort with:
- Obstructive HCM
- Males and females between 18 and 65 years of age
- BMI < 35 kg/m2
- LVOT-G at entry as follows:
- Resting gradient ≥50 mmHg OR Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
Show all 12Show fewer
- NYHA Class II or III or
- Non-obstructive HCM
- Same criteria as above except resting LVOT-G is <30mmHg and post-Valsalva gradient <50mm Hg
- BMI <40kg/m2
- Elevated NT-proBNP > 300 pg/mL at the time of enrollment
- LVEF ≥55%
Who cannot join
- Paroxysmal atrial fibrillation or flutter documented prior to entry.
- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to entry. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months.)
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to entry.
- Pregnancy due to potential risk of gadolinium to the fetus
- Patients with a pacemaker that are pacer-dependent as they cannot undergo MRI
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Thuy Le contact
8 sites in 2 countries
United States6 sites, 6 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Adam Helms, MD, 734-764-4500, adamhelm@med.umich.edu
- Not yet recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Carolyn Ho, MD, 617-732-5685, cho@bwh.harvard.edu
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Niki Sprouse, 434-982-1058, NJB6M@uvahealth.org
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Milind Desai, MD, 216-445-5250, desaim2@ccf.org
- Not yet recruiting
Tufts Medical Center
Medford, Massachusetts, 02155
Christopher Madias, MD, 617-636-5902, cmadias@tuftsmedicalcenter.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Kayla Syring, (507) 284-4253, syring.kayla@mayo.edu
Jeffrey Geske, MD
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
William Bradlow, MD, +44(0)121 371 4448, William.Bradlow@uhb.nhs.uk
- Recruiting
Barts Health NHS Trust
London, E2 9JX
Saidi Mohiddin, MD, +44(0)70 3765 8614, smohiddin@doctors.org
James Easton, james.easton3@nhs.net
About this study
This study aims to learn what might predict heart problems (like sudden death from a fast heart rhythm or heart failure) in people with a genetic condition called hypertrophic cardiomyopathy (HCM). HCM causes the heart muscle to become thick, which can make the heart stiff and harder to work properly. It can also affect the heart's electrical system.
This study is looking to enroll patients that were previously part of a research project called "HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy." The results of that study are still being reviewed, but they might show that people who had a substance called Gadolinium (MRI contrast or dye) collected in their heart muscle may have a higher risk for heart problems, including sudden cardiac death. This is called "late gadolinium enhancement" (LGE). This study is aiming to do follow-up imaging on those patients to better understand how LGE affects people with HCM.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- None - observational study
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - observational studyOther
None - observational study
| Study group | Role | What they receive |
|---|---|---|
| Obstructive HCM | Not described Receives: Other: None - observational study | |
| Non-obstructive HCM | Not described Receives: Other: None - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in % LGE mass
To assess the change in LGE extent from baseline over a minimum of 7 years of follow-up extent in HCM patients who would have been candidates for clinical trials of aficamten.
Measured: From baseline over a minimum of 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start27 Jul 2026
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- 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
- 314 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Christopher Kramer
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Mayo Clinic, Tufts Medical Center, Northwestern University, University of Michigan, The Cleveland Clinic, University Hospital Birmingham NHS Foundation Trust, Glenfield Hospital, Leicester, London Chest Hospital, Cytokinetics, Toronto General Hospital
- Responsible party
- Sponsor-investigator, Christopher Kramer, University of Virginia
- Investigators
- Christopher Kramer, MD, Principal investigator, University of VirginiaStefan Neubauer, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054073
- Sponsor's protocol ID
- 302244
- Status last verified
- Mar 2026
- First submitted
- 27 Jun 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCMR Re-Imaging Study
- ClinicalTrials.gov ID
- NCT07054073
- Acronym / sponsor ID
- 302244
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Christopher KramerUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Mayo Clinic, Tufts Medical Center, Northwestern University, University of Michigan, The Cleveland Clinic, University Hospital Birmingham NHS Foundation Trust, Glenfield Hospital, Leicester, London Chest Hospital, Cytokinetics, Toronto General Hospital
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Jul 2025 (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.
This study aims to learn what might predict heart problems (like sudden death from a fast heart rhythm or heart failure) in people with a genetic condition called hypertrophic cardiomyopathy (HCM). HCM causes the heart muscle to become thick, which can make the heart stiff and harder to work properly. It can also affect the heart's electrical system.
This study is looking to enroll patients that were previously part of a research project called "HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy." The results of that study are still being reviewed, but they might show that people who had a substance called Gadolinium (MRI contrast or dye) collected in their heart muscle may have a higher risk for heart problems, including sudden cardiac death. This is called "late gadolinium enhancement" (LGE). This study is aiming to do follow-up imaging on those patients to better understand how LGE affects people with HCM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive HCM | – | Other: None - observational study |
| Non-obstructive HCM | – | Other: None - observational study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from the HCMR original cohort who also meet this study's eligibility criteria.
Key inclusion criteria (12 listed)
- Obstructive HCM
- Resting gradient ≥50 mmHg OR Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
- Non-obstructive HCM
Key exclusion criteria (5 listed)
- Paroxysmal atrial fibrillation or flutter documented prior to entry.
- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to entry. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months.)
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to entry.
- Pregnancy due to potential risk of gadolinium to the fetus
- Patients with a pacemaker that are pacer-dependent as they cannot undergo MRI
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 |
|---|---|---|
| None - observational studyNone - observational study | Other | Non-obstructive HCM, Obstructive HCM |
Primary outcome
Change in % LGE mass
Time frame: From baseline over a minimum of 7 years
To assess the change in LGE extent from baseline over a minimum of 7 years of follow-up extent in HCM patients who would have been candidates for clinical trials of aficamten.
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 16 Oct 2026.
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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.
Thuy Le contact
Christopher Kramer, MD principal investigator
University of Virginia
Stefan Neubauer, MD principal investigator
University of Oxford
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Christopher Kramer at 8 sites in 2 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 12 inclusion and 5 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. 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 Gina Duda (434-924-9553, gms4x@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in % LGE mass (time frame: From baseline over a minimum of 7 years). 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 16 Oct 2026.