Hypertrophic Cardiomyopathy (HCM)MERIT HCMNCT07332767
Myocardial Energetic Restoration in the Treatment of Obstructive Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy (HCM), run by University of Manchester.
Trial summary
Hypertrophic Cardiomyopathy (HCM) is the most common inherited heart condition, where the heart muscles can thicken to the point of obstructing blood flow out of the heart. This condition is associated with a chronic state of energy loss in the heart muscle. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to Apr 2028
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort consists of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who are clinically eligible for and planning to initiate treatment with mavacamten.
Who may be able to join
- at least 18 years of age and
- Have a confirmed diagnosis of oHCM that is not solely explained by abnormal loading conditions such as significant hypertension or valvular disease
- Qualify for mavacamten therapy by exhibiting a peak Left Ventricular Outflow Tract (LVOT) gradient of ≥ 50mmHg at rest or with provocation, New York Heart Association (NYHA) functional class II or III symptoms, and a baseline Left Ventricular Ejection Fraction (LVEF) of ≥ 55%
Who cannot join
- HCM phenocopies such as cardiac amyloidosis or Fabry's disease
- Undergone a septal reduction therapy (myectomy or ablation) within the preceding 6 months
- Any contraindications to mavacamten (e.g., baseline LVEF < 55%, pregnancy/breastfeeding)
- Inability to safely undergo a cardiac MRI, such as having non-compatible metal implants or severe claustrophobia
About this study
Hypertrophic Cardiomyopathy (HCM) is the most common inherited heart condition, where the heart muscles can thicken to the point of obstructing blood flow out of the heart. This condition is associated with a chronic state of energy loss in the heart muscle.
Till more recently, a new class of medication (cardiac myosin inhibitors) have been introduced to directly target the heart muscle proteins (sarcomeres) to reduce the strength of contraction and relieve obstruction of blood flow out of the heart. While clinical trials have shown this class of medication significantly improves physical capacity and patient symptoms, it is still unclear, based on small scale published studies, where this improvement is achieved by restoring the fundamental energy balance within the heart.
Our research study aims to answer this question and prove mechanistic insights of the use of this class of medication in the HCM population with blood flow obstruction (otherwise known as obstructive HCM) by using a specialised non-invasive MRI technique which accurately measures the heart energy score (specifically known as the PCr/ATP ratio) in each participant. Our objective is to determine how a patient with obstructive HCM have their energy scores affected, and improve over time with this medication therapy. If positive, this finding could establish the use of PCr/ATP ratio as a crucial, objective biomarker for monitoring therapeutic response and informing personalised dosing strategies for patient in the future.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- hypertrophic cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in PCr/ATP ratio
The main goal is to determine if mavacamten therapy (cardiac myosin inhibitor) significantly improves the heart-muscle energy levels of patients with obstructive hypertrophic cardiomyopathy, as measured by the "energy score" (PCr/ATP) on a specialised MRI scan.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start30 Apr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 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.
- More trials run by University of ManchesterThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Jun How, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332767
- Sponsor's protocol ID
- 367806
- Acronym
- MERIT HCM
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Energetic Restoration in the Treatment of Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07332767
- Acronym / sponsor ID
- MERIT HCM / 367806
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- hypertrophic cardiomyopathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 12 Jan 2026 (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.
Hypertrophic Cardiomyopathy (HCM) is the most common inherited heart condition, where the heart muscles can thicken to the point of obstructing blood flow out of the heart. This condition is associated with a chronic state of energy loss in the heart muscle.
Till more recently, a new class of medication (cardiac myosin inhibitors) have been introduced to directly target the heart muscle proteins (sarcomeres) to reduce the strength of contraction and relieve obstruction of blood flow out of the heart. While clinical trials have shown this class of medication significantly improves physical capacity and patient symptoms, it is still unclear, based on small scale published studies, where this improvement is achieved by restoring the fundamental energy balance within the heart.
Our research study aims to answer this question and prove mechanistic insights of the use of this class of medication in the HCM population with blood flow obstruction (otherwise known as obstructive HCM) by using a specialised non-invasive MRI technique which accurately measures the heart energy score (specifically known as the PCr/ATP ratio) in each participant. Our objective is to determine how a patient with obstructive HCM have their energy scores affected, and improve over time with this medication therapy. If positive, this finding could establish the use of PCr/ATP ratio as a crucial, objective biomarker for monitoring therapeutic response and informing personalised dosing strategies for patient in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort consists of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who are clinically eligible for and planning to initiate treatment with mavacamten.
Key inclusion criteria (3 listed)
- at least 18 years of age and
- Have a confirmed diagnosis of oHCM that is not solely explained by abnormal loading conditions such as significant hypertension or valvular disease
- Qualify for mavacamten therapy by exhibiting a peak Left Ventricular Outflow Tract (LVOT) gradient of ≥ 50mmHg at rest or with provocation, New York Heart Association (NYHA) functional class II or III symptoms, and a baseline Left Ventricular Ejection Fraction (LVEF) of ≥ 55%
Key exclusion criteria (4 listed)
- HCM phenocopies such as cardiac amyloidosis or Fabry's disease
- Undergone a septal reduction therapy (myectomy or ablation) within the preceding 6 months
- Any contraindications to mavacamten (e.g., baseline LVEF < 55%, pregnancy/breastfeeding)
- Inability to safely undergo a cardiac MRI, such as having non-compatible metal implants or severe claustrophobia
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
Mean change in PCr/ATP ratio
Time frame: 24 weeks
The main goal is to determine if mavacamten therapy (cardiac myosin inhibitor) significantly improves the heart-muscle energy levels of patients with obstructive hypertrophic cardiomyopathy, as measured by the "energy score" (PCr/ATP) on a specialised MRI scan.
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 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy (HCM), run by University of Manchester.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Mean change in PCr/ATP ratio (time frame: 24 weeks). 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 12 Jan 2026.