RELIEVE METAB Study

ConditionHeart Failure With Reduced Ejection Fraction (HFrEF)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHeinrich-Heine University, Duesseldorf

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Hemodynamics: Resting SBP < 90 or > 160 mmHg

Severe PH (PASP >70 mmHg, PVR > 4 Wood Units)

intracardiac thrombus

Severe RV dysfunction (TAPSE <12 mm or RVFAC ≤25%)

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: IASD therapy in HFrEFOther 2 interventions

Trial outcomes

Primary outcomes

Reverse LV remodeling

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

Time frame

Baseline to 12 months

Secondary outcomes

Myocardial Energy metabolism

Improvement in myocardial energy metabolism at rest and during exercise, measured as an increase in the myocardial PCr/ATP ratio after Ventura IASD implantation determined by 31P-MRS

Time frame

Baseline to 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heinrich-Heine University, Duesseldorf

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: