Heart Failure With Reduced Ejection Fraction (HFrEF)NCT07555925
RELIEVE METAB Study
A study testing cardiac MRI and Functional Testing in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- cardiac MRI and Functional Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Amin Polzin, MD
Mareike Cramer, MD
About this study
Official title: Interatrial Shunt Device (IASD) Treatment in Symptomatic Heart Failure With Reduced Left Ventricular Ejection Fraction (HFrEF) Alleviates Elevated Myocardial Left Ventricular Pressures, Improves Myocardial Mitochondrial Function and Promotes Regional and Global Myocardial Recovery
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.
Read the detailed description
All patients receive standard of care percutaneous implantation of the interatrial Ventura shunt according to the instructions for use. Cardiac function, volumes, pressures, and energy efficiency will be determined by state-of-the-art clinical multiparametric cMRI and spectroscopy (MRS) at baseline, 3-months, and 12-months follow-up. Systemic mitochondrial respiratory function will be determined by established Oroboros and Seahorse protocols.
Post-procedural assessments include:
- 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.
- Laboratory \& Biomarkers: Blood sampling for systemic mitochondrial respiratory function (PBMC respirometry via Oroboros® and Seahorse® protocols) and serum metabolomic testing.
- Clinical Follow-up: NYHA classification, quality of life assessment using the Kansas City Cardiomyopathy Questionnaire (KCCQ), and standard-of-care echocardiography.
- Being tested
- cardiac MRI, Functional Testing
- Keywords
- Interatrial Shunt Device (IASD), Ventura Shunt, Myocardial Energetics, Mitchondrial Function, MRI, CMR, MRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac MRIOther
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 TestingOther
Cardiopulmonary exercise testing (CPET) to quantify functional capacity via VO2 max and standardized symptom assessment in the heart failure unit.
| Study group | Role | What they receive |
|---|---|---|
| IASD therapy in HFrEF | Other | All patients receive standard of care percutaneous implantation of the interatrial Ventura shunt according to the instructions for use. Receives: Other: cardiac MRI; Other: Functional Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reverse LV remodeling
The primary endpoint is to achieve reverse remodeling detected by gold standard cMRI, comparing left-ventricular end-diastolic volume (LVEDV).
Measured: Baseline to 12 months
Secondary outcomes (1)
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
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, MD, Study director, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555925
- Sponsor's protocol ID
- RELIEVE METAB
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interatrial Shunt Device (IASD) Treatment in Symptomatic Heart Failure With Reduced Left Ventricular Ejection Fraction (HFrEF) Alleviates Elevated Myocardial Left Ventricular Pressures, Improves Myocardial Mitochondrial Function and Promotes Regional and Global Myocardial Recovery
- ClinicalTrials.gov ID
- NCT07555925
- Acronym / sponsor ID
- RELIEVE METAB
- Keywords
- Interatrial Shunt Device (IASD), Ventura Shunt, Myocardial Energetics, Mitchondrial Function, MRI, CMR, MRS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All patients receive standard of care percutaneous implantation of the interatrial Ventura shunt according to the instructions for use. Cardiac function, volumes, pressures, and energy efficiency will be determined by state-of-the-art clinical multiparametric cMRI and spectroscopy (MRS) at baseline, 3-months, and 12-months follow-up. Systemic mitochondrial respiratory function will be determined by established Oroboros and Seahorse protocols.
Post-procedural assessments include:
- 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.
- Laboratory \& Biomarkers: Blood sampling for systemic mitochondrial respiratory function (PBMC respirometry via Oroboros® and Seahorse® protocols) and serum metabolomic testing.
- Clinical Follow-up: NYHA classification, quality of life assessment using the Kansas City Cardiomyopathy Questionnaire (KCCQ), and standard-of-care echocardiography.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IASD therapy in HFrEF | Other | Other: cardiac MRI, Other: Functional TestingAll patients receive standard of care percutaneous implantation of the interatrial Ventura shunt according to the instructions for use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- Hemodynamics: Resting SBP < 90 or > 160 mmHg
- Severe PH (PASP >70 mmHg, PVR > 4 Wood Units)
- Anatomy/Structure:
- Valvular Disease:
- Recent Events:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac MRICardiac 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 | Other | IASD therapy in HFrEF |
| Functional TestingCardiopulmonary exercise testing (CPET) to quantify functional capacity via VO2 max and standardized symptom assessment in the heart failure unit. | Other | IASD therapy in HFrEF |
Primary outcome
Reverse LV remodeling
Time frame: Baseline to 12 months
The primary endpoint is to achieve reverse remodeling detected by gold standard cMRI, comparing left-ventricular end-diastolic volume (LVEDV).
1 secondary outcome
Myocardial Energy metabolism
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malte Kelm, MD study director
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac MRI and Functional Testing in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amin Polzin, MD (+49 2118105187, ctu@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reverse LV remodeling (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.