NCT07150299Recruiting
Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 24 Aug 2025
- Start date
- 5 Sept 2025
- Primary completion date
- 31 May 2027
- Lead sponsor
- Medical University of Vienna
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07150299
What you commit to
- Study type: Observational
- Planned participants: 20
- From 5 Sept 2025 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known allergy to contrast agent
- Alternative disease causing hypertrophic cardiomyopathy (e.g. cardiac amyloidosis, Morbus Fabry)
Lab values
- Significant hepatic impairment defined as 3x upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase; hepatic cirrhosis
Other
- Claustrophobia or other contraindication for CMR imaging
- Glomerular filtration rate \< 30ml/min/m2
- Pregnant women (and women with childbearing potential with desire for pregnancy)
- Breastfeeding women
- Unwillingness to comply with the study protocol and its procedures
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.