CClinicalTrials.gg
RecruitingNCT07150299oHCMUpdated Sep 2, 2025

Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy

An observational study in Hypertrophic Obstructive Cardiomyopathy \(HOCM\), sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hypertrophic Obstructive Cardiomyopathy \(HOCM\)

Keywords

  • Myocardial Perfusion
03

In context

Cardiomyopathy, Hypertrophic

347 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 110 are open to participants now.

This study's planned enrollment of 20 is below the median of 259 across 168 observational studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with oHCM on maximal tolerated background therapy which will receive mavacamten as add-on

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • DrugMavacamten in clinical routine use

    Clinical observation of mavacamten use

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year of maximal tolerated dose of mavacamten

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

  • Study protocol · Jul 22, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07150299
Lead sponsor
Medical University of Vienna
Responsible party
Daniel Dalos (Chief resident, Medical University of Vienna) — Principal investigator
First posted
Sep 2, 2025
Start date
Sep 5, 2025 (estimated)
Primary completion
May 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion