Hypertrophic Obstructive Cardiomyopathy \(HOCM\)oHCMNCT07150299
Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Obstructive Cardiomyopathy \(HOCM\), run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background: Microvascular dysfunction is a hallmark of hypertrophic obstructive cardiomyopathy (HOCM) and can be visualized non-invasively using cardiac magnetic resonance (CMR) perfusion imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy \(HOCM\)
- What is being tested?
- Mavacamten in clinical routine use
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 5 Sep 2025to Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with oHCM on maximal tolerated background therapy which will receive mavacamten as add-on
Who may be able to join
- Age > 18 years
- Willingness to provide written informed consent
- Diagnosis of obstructive HCM based on ESC 2023 criteria
- Planned CMR with myccardial perfusion for clinical purposes
- Receiving guideline-conform OMT
- Ability and willingness to undergo follow-up imaging and testing
- Written informed consent
Who cannot join
- Claustrophobia or other contraindication for CMR imaging
- Significant coronary artery disease and/or prior stent implantation or coronary artery bypass graft surgery
- History of sudden cardiac arrest or sustained ventricular arrhythmia 12 months prior to screening
- Glomerular filtration rate < 30ml/min/m2
- Significant hepatic impairment defined as 3x upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase; hepatic cirrhosis
- Known allergy to contrast agent
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- Alternative disease causing hypertrophic cardiomyopathy (e.g. cardiac amyloidosis, Morbus Fabry)
- Pregnant women (and women with childbearing potential with desire for pregnancy)
- Breastfeeding women
- Unwillingness to comply with the study protocol and its procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 2362
Daniel Dalos, PD DDr., +43 1 40400 46140, daniel.dalos@meduniwien.ac.at
Christopher Mann, Dr., christopher.mann@meduniwien.ac.at
About this study
Background: Microvascular dysfunction is a hallmark of hypertrophic obstructive cardiomyopathy (HOCM) and can be visualized non-invasively using cardiac magnetic resonance (CMR) perfusion imaging. In parallel, the six-minute walk test (6MWT) is an established clinical tool to assess submaximal exercise capacity in patients with structural heart disease. Despite its widespread use, the relationship between objective changes in myocardial perfusion and functional improvements assessed by the 6MWT remains insufficiently explored in patients with HOCM on optimal medical therapy (OMT).
Aim:This study aims to evaluate whether changes in functional capacity, measured by the 6MWT, correlate with changes in myocardial perfusion reserve (MPR) in HOCM patients treated with OMT.
Read more
Methods: We will include patients diagnosed with obstructive HCM who previously underwent clinically indicated CMR perfusion scans for risk stratification. These patients are regularly followed in the HCM outpatient clinic of the Medical University of Vienna, where standardized 6MWTs are performed in routine care. Approximately one year after the baseline CMR, a follow-up CMR will be conducted to assess changes in perfusion parameters. This second CMR is clinically justified for improved individual risk stratification as recommended by the 2023 ESC Guidelines on Cardiomyopathies.
The primary objective is to assess the correlation between the change in the walking distance in the 6MWT and the change in MPR over a one-year interval. Secondary endpoints include changes in myocardial blood flow (MBF) at rest and during pharmacological stress. All assessments will be integrated with clinical, echocardiographic, and laboratory evaluations.
- Being tested
- Mavacamten in clinical routine use
- Keywords
- Myocardial Perfusion
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mavacamten in clinical routine useDrug
Clinical observation of mavacamten use
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between myocardial perfusion reserve changes and changes in the performed distance in 6MWT.
Correlation between myocardial perfusion reserve changes and changes in the performed distance in 6MWT.
Measured: One year of maximal tolerated dose of mavacamten
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start5 Sep 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive Cardiomyopathy \(HOCM\)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Dalos, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150299
- Sponsor's protocol ID
- CV027-1201
- Other IDs
- 1492/2025
- Acronym
- oHCM
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07150299
- Acronym / sponsor ID
- oHCM / CV027-1201
- Keywords
- Myocardial Perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Sep 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.
Background: Microvascular dysfunction is a hallmark of hypertrophic obstructive cardiomyopathy (HOCM) and can be visualized non-invasively using cardiac magnetic resonance (CMR) perfusion imaging. In parallel, the six-minute walk test (6MWT) is an established clinical tool to assess submaximal exercise capacity in patients with structural heart disease. Despite its widespread use, the relationship between objective changes in myocardial perfusion and functional improvements assessed by the 6MWT remains insufficiently explored in patients with HOCM on optimal medical therapy (OMT).
Aim:This study aims to evaluate whether changes in functional capacity, measured by the 6MWT, correlate with changes in myocardial perfusion reserve (MPR) in HOCM patients treated with OMT.
Methods: We will include patients diagnosed with obstructive HCM who previously underwent clinically indicated CMR perfusion scans for risk stratification. These patients are regularly followed in the HCM outpatient clinic of the Medical University of Vienna, where standardized 6MWTs are performed in routine care. Approximately one year after the baseline CMR, a follow-up CMR will be conducted to assess changes in perfusion parameters. This second CMR is clinically justified for improved individual risk stratification as recommended by the 2023 ESC Guidelines on Cardiomyopathies.
The primary objective is to assess the correlation between the change in the walking distance in the 6MWT and the change in MPR over a one-year interval. Secondary endpoints include changes in myocardial blood flow (MBF) at rest and during pharmacological stress. All assessments will be integrated with clinical, echocardiographic, and laboratory evaluations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oHCM on maximal tolerated background therapy which will receive mavacamten as add-on
Key inclusion criteria (7 listed)
- Age > 18 years
- Willingness to provide written informed consent
- Diagnosis of obstructive HCM based on ESC 2023 criteria
- Planned CMR with myccardial perfusion for clinical purposes
- Receiving guideline-conform OMT
Key exclusion criteria (10 listed)
- Claustrophobia or other contraindication for CMR imaging
- Significant coronary artery disease and/or prior stent implantation or coronary artery bypass graft surgery
- History of sudden cardiac arrest or sustained ventricular arrhythmia 12 months prior to screening
- Glomerular filtration rate < 30ml/min/m2
- Significant hepatic impairment defined as 3x upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase; hepatic cirrhosis
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 |
|---|---|---|
| Mavacamten in clinical routine useClinical observation of mavacamten use | Drug | – |
Primary outcome
Correlation between myocardial perfusion reserve changes and changes in the performed distance in 6MWT.
Time frame: One year of maximal tolerated dose of mavacamten
Correlation between myocardial perfusion reserve changes and changes in the performed distance in 6MWT.
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 2 Sep 2025.
- 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.
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 Hypertrophic Obstructive Cardiomyopathy \(HOCM\), run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 10 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 2 Sep 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 Austria. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between myocardial perfusion reserve changes and changes in the performed distance in 6MWT. (time frame: One year of maximal tolerated dose of mavacamten). 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 2 Sep 2025.