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Clinical Trials in Germany / NCT07555925
Starting soon Not applicable

RELIEVE METAB Study

NCT07555925 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2026-06-01
Last updated
2026-04-29

Condition(s) studied

Heart Failure With Reduced Ejection Fraction (HFrEF)

Investigational drug(s) / intervention(s)

cardiac MRIFunctional Testing

cardiac MRI: Cardiac Imaging: Multiparametric cardiac MRI (cMRI) and Phosphorus-31 Magnetic Resonance Spectroscopy (³¹P-MRS) at rest and during cycle ergometry to evaluate ventricular volumes, pressures, and myocardial energy efficiency

Functional Testing: Cardiopulmonary exercise testing (CPET) to quantify functional capacity via VO2 max and standardized symptom assessment in the heart failure unit.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Ischemic or non-ischemic cardiomyopathy with LVEF ≤ 40% 2. Patient is eligible and scheduled to receive the Ventura IASD as per the current IFU. 3. Symptoms: NYHA Class III 4. Stability: Chronic heart failure for ≥ 6 months on stable, and at least 3 months on guideline-directed medical therapy (GDMT) 5. Biomarkers: NTproBNP ≥ 1,200 pg/ml 6. Age 18 years or older 7. 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. Exclusion Criteria: 1. Hemodynamics: Resting SBP \< 90 or \> 160 mmHg 2. Severe PH (PASP \>70 mmHg, PVR \> 4 Wood Units) 3. Anatomy/Structure: * intracardiac thrombus * Severe RV dysfunction (TAPSE \<12 mm or RVFAC ≤25%) * LVEDD \> 8 cm * Significant ASD or PFO 4. Valvular Disease: * Severe, untreated mitral stenosis or aortic stenosis or regurgitation * Mitral repair device \<3 months prior to enrollment 5. Recent Events: * ACS, PCI, Cardiac Surgery (\< 3 months prior to enrollment) * CAD requiring revascularization * Stroke, TIA, PE, Thrombosis (\< 6 months prior to enrollment) 6. Issues undergoing MRI: e.g non-compatible implant, claustrophobia, or physically not suitable for MRI 7. 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 8. 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 9. Any non-cardiac condition with life expectancy \<1 years (e.g., cirrhosis, cancer not in remission, etc.) 10. Subject belongs to a vulnerable population

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Duesseldorf Düsseldorf North Rhine-Westphalia

More Heinrich-Heine University, Duesseldorf trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07555925 on ClinicalTrials.gov ↗ ← All trials in Germany