RELIEVE METAB Study

Starting soon · Not applicable

Conditions studied: Heart Failure With Reduced Ejection Fraction (HFrEF)

In brief

This prospective, single-center post-market-follow-up study aims to fill knowledge gaps by combining advanced cardiac MRI/MRS with systemic mitochondrial assays and exercise testing to characterize the energetic and functional impact of IASD therapy in HFrEF patients.

Key facts

Study ID

NCT07555925

Run by

Heinrich-Heine University, Duesseldorf

People needed

15

Starts

2026-06-01

Expected to finish

2027-07-01

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ischemic or non-ischemic cardiomyopathy with LVEF ≤ 40%
• Patient is eligible and scheduled to receive the Ventura IASD as per the current IFU.
• Symptoms: NYHA Class III
• Stability: Chronic heart failure for ≥ 6 months on stable, and at least 3 months on guideline-directed medical therapy (GDMT)
• Biomarkers: NTproBNP ≥ 1,200 pg/ml
• Age 18 years or older
• Subject has signed informed consent form and is willing and able to attend all follow-up visits and is physically capable of performing all tests.

You may not qualify if…

• Hemodynamics: Resting SBP < 90 or > 160 mmHg
• Severe PH (PASP >70 mmHg, PVR > 4 Wood Units)
• Anatomy/Structure:
• intracardiac thrombus
• Severe RV dysfunction (TAPSE <12 mm or RVFAC ≤25%)
• LVEDD > 8 cm
• Significant ASD or PFO
• Valvular Disease:
• Severe, untreated mitral stenosis or aortic stenosis or regurgitation
• Mitral repair device <3 months prior to enrollment
• Recent Events:
• ACS, PCI, Cardiac Surgery (< 3 months prior to enrollment)
• CAD requiring revascularization
• Stroke, TIA, PE, Thrombosis (< 6 months prior to enrollment)
• Issues undergoing MRI: e.g non-compatible implant, claustrophobia, or physically not suitable for MRI
• Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
• Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
• Any non-cardiac condition with life expectancy <1 years (e.g., cirrhosis, cancer not in remission, etc.)
• Subject belongs to a vulnerable population

Where it is running

• University Hospital Duesseldorf — Düsseldorf, North Rhine-Westphalia, Germany

Full record on ClinicalTrials.gov

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