RELIEVE METAB Study

NCT07555925 | Not Yet Recruiting

• 1 other identifier: RELIEVE METAB
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Keywords

Interatrial Shunt Device (IASD); Ventura Shunt; Myocardial Energetics; Mitchondrial Function; MRI; CMR; MRS

Outcome Measures

Primary Outcomes (1)

• Reverse LV remodeling

  The primary endpoint is to achieve reverse remodeling detected by gold standard cMRI, comparing left-ventricular end-diastolic volume (LVEDV).

  Baseline to 12 months

Secondary Outcomes (1)

• Myocardial Energy metabolism

  Baseline to 12 months

Study Arms (1)

IASD therapy in HFrEF

OTHER

All patients receive standard of care percutaneous implantation of the interatrial Ventura shunt according to the instructions for use.

Other: cardiac MRI; Other: Functional Testing

Interventions

cardiac MRI OTHER

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

IASD therapy in HFrEF

Functional Testing OTHER

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

IASD therapy in HFrEF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Study Officials

• Malte Kelm, MD

  Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

  STUDY DIRECTOR

Central Study Contacts

Amin Polzin, MD

CONTACT

+49 2118105187; ctu@med.uni-duesseldorf.de

Lisa Dannenberg, MD

CONTACT

+49 2118105187; LisaKristina.Dannenberg@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DE (1)