Heart FailureARCADIA-HFNCT06868797
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
A study testing Biological sample for the measurement of suPAR levels. in people with Heart Failure, run by Central Hospital, Nancy, France at 11 sites in France.
Trial summary
Heart failure affects 1 to 2% of the adult population in developed countries, representing about 55 million people worldwide. Advanced heart failure is a condition where the heart can no longer provide sufficient cardiac output or equilibrate pressures within its chambers, leading to symptoms such as shortness of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Biological sample for the measurement of suPAR levels.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 11 sitesFrance
- Study dates
- 29 Aug 2025to 12 Sep 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
- Age ≥ 18 years and ≤ 85 years
- NYHA class ≥3
- LVEF ≤ 35%
- On GDMT (including dapagliflozin) based on current heart failure practice guidelines at maximal tolerated dose
- On waiting list (or on the registration pathway) for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant ≥ 6 months or in a pre-transplant pathway.
- Person affiliated to a social security scheme or beneficiary of such a scheme.
- A person who has received full information about the organization of the clinical research and has signed an informed consent form.
Who cannot join
- Priority patient on waiting list for heart transplantation.
- Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.
- Inotrope dependent, existence of ongoing mechanical circulatory support
- Current acute decompensated HF or hospitalization due to decompensated HF <30 days prior to the enrolment.
- History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion.
- Any recent interventional procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) < 60 days.
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- Glomerular filtration rate <25 ml/min/1.73 m2, according to CKD-EPI formula
- Unstable or rapidly progressing renal disease (autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis).
- Type 1 diabetes mellitus.
- Participation in another clinical interventional trial.
- Any condition other than heart failure that could limit survival to less than 12 months.
- Pregnant women or breastfeeding mothers
- vulnerable persons (guardianship, curatorship, safeguard of justice)
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
Hospice Civil de Lyon - Hôpital Louis PRADEL
Bron, 69500
Nathan MEWTON, MD-PhD, +33 (0)4 72 11 80 88, nathan.mewton@chu-lyon.fr
Nathan MEWTON, MD-PhD
- Not yet recruiting
CHU Grenoble
La Tronche, 38700
Aude BOIGNARD, MD, +33(0) 476 76 75 75, ABoignard@chu-grenoble.fr
Aude Boignard, MD
- Not yet recruiting
CHU Montpellier
Montpellier, 34295
Valentin DUPASQUIER, MD-PhD, +33(0)4 67 33 67 33, valentin.dupasquier@chu-montpellier.fr
VALENTIN DUPASQUIER, MD-PhD
- Not yet recruiting
Chu Nantes
Nantes, 44093
Sabine PATTIER, MD-PhD, +33 (0)2 40 08 33 33, sabine.pattier@chu-nantes.fr
Sabine PATTIER, MD-PhD
- Not yet recruiting
Aphp Hegp
Paris, 75015
Anne Céline MARTIN, MD-PhD, +33(0)1 56 09 20 00, anne-celine.martin@aphp.fr
Anne Céline MARTIN, MD-PhD
- Not yet recruiting
CHU Bordeaux
Pessac, 33600
Maxime FAURE, MD-PhD, +33(0)5 56 79 56 79, maxime.faure@chu-bordeaux.fr
Maxime FAURE, MD-PhD
- Not yet recruiting
CHU Rennes
Rennes, 35033
Céline CHABANNES, MD-PhD, +33(0)2 99 28 43 21, Celine.CHABANNE@chu-rennes.fr
Céline CHABANNES, MD-PhD
- Not yet recruiting
Chu Rouen
Rouen, 76031
Charles FAUVEL, MD-PhD, +33(0)2 32 88 89 90, Charles.Fauvel@chu-rouen.fr
Charles FAUVEL, MD-PhD
- Not yet recruiting
CHU Strasbourg
Strasbourg, 67091
Jean Jacques VON HUNOLSTEIN, MD-PhD, +33(0)3 88 11 67 68, Jean-Jacques.VONHUNOLSTEIN@chru-strasbourg.fr
Jean Jacques VON HUNOLSTEIN, MD-PhD
- Not yet recruiting
CHU de Toulouse
Toulouse, 31059
Romain ITIER, MD-PhD, +33(0)5 61 77 22 33, itier.r@chu-toulouse.fr
Romain ITIER, MD-PhD
- Recruiting
Chru Nancy
Vandœuvre-lès-Nancy, 54500
Guillaume BAUDRY, MD, +33(0)383157322, g.baudry@chru-nancy.fr
Guillaume BAUDRY, MD
About this study
Heart failure affects 1 to 2% of the adult population in developed countries, representing about 55 million people worldwide.
Advanced heart failure is a condition where the heart can no longer provide sufficient cardiac output or equilibrate pressures within its chambers, leading to symptoms such as shortness of breath, fatigue, and water and salt retention.
Read more
Heart failure affects the kidneys by reducing blood flow directed to them, sometimes leading to kidney congestion. In the long term, this can degrade kidney function. Common medications used to treat heart failure, such as diuretics, can sometimes worsen kidney failure. This link between the heart and the kidneys is known as cardio-renal syndrome and requires careful management of both organs to prevent mutual degradation.
Dapagliflozin is an SGLT2 inhibitor medication used to treat type 2 diabetes, heart failure, and certain kidney diseases. It helps reduce blood sugar, improve heart and kidney function, while promoting the elimination of excess salt and water.
However, there are limited data regarding the progression of cardio-renal interactions in patients with advanced heart failure. Yet, advanced heart failure is often associated with kidney dysfunction.
The protein called suPAR is found in the blood of patients developing kidney disease and/or during the onset of acute kidney injury. This protein will allow to characterize a population of patients with advanced heart failure receiving optimized medical treatment, including dapagliflozin.
The main objective of this research is to assess, based on the suPAR protein level in the blood, the progression of cardio-renal damage between inclusion and 6 months in patients with advanced heart failure who are listed for a heart transplant and treated with a therapy including dapagliflozin.
The study plans 5 visits over 12 months. The research will take place in the cardiology department of several French hospitals.
- Conditions
- Heart Failure
- Being tested
- Biological sample for the measurement of suPAR levels.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample for the measurement of suPAR levels.Other
Biological sample for the measurement of plasminogen activator receptor (suPAR) level at baseline and at 6 months follow up to assess the evolution of cardio-renal interaction in HF patients listed for heart transplant treated by GDMT including dapagliflozin.
| Study group | Role | What they receive |
|---|---|---|
| Patients followed for end-stage heart failure | Other | Patients followed for end-stage heart failure and waiting for heart transplantation. This cohort will focus on cardio-renal assessment of advanced HF patients treated with optimal pharmacologic therapy including dapagliflozin. The biological material and clinical data collected will allow us to better understand the advanced HF and to generate new research hypotheses. Receives: Other: Biological sample for the measurement of suPAR levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml)
the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml) between the baseline and 6 months of follow-up.
Measured: baseline and 6 months of follow-up.
Secondary outcomes (26)
VO2 max
Functional status at baseline and 6 months assessed by VO2 max assessment
Measured: baseline and 6 months of follow-up.
Delta GFR estimated by CKD-EPI formula (ml/min/1.73m²)
The following parameters are collected at baseline to identify predictive factors associated with secondary endpoint. These parameters should not be considered as endpoints themselves:
- Hemodynamic Parameters: cardiac output (L/min), pulmonary capillary wedge pressure (mmHg), pulmonary artery systolic and mean pressure (mmHg), right atrial pressure (mmHg).
- Echocardiographic Parameters: LVEF (%), mitral regurgitation grade (0-4), left atrial volume (mL /m2).
- Biological Parameters: Nt-proBNP (ng/L), Creatinine (µmol/L), GFR evaluate by Iohexol clearance (ml/min) or other method (ml/min) (inuline, EDTA chrome51 (51Cr EDTA), Iothalamate clearance),plasma volume calculated from haemoglobin (g/L) and haematocrit,(%) bilirubin (µmol/L), AST (UI/L), ALT (UI/L), kalemia (mmol/L), cystatin C (mg/L), sST2 (ng/mL), gremlins 1(pg/mL), FGF 23 (C terminal and intact) (pg/mL).
- Congestion Markers: Clinical, biological, echocardiographic, and hemodynamic markers.
Measured: baseline and 6 months of follow-up.
Rate of composite outcome (hospitalization for acute heart failure or all cause death).
The following parameters are collected at baseline to identify predictive factors associated with secondary endpoint. These parameters should not be considered as endpoints themselves:
- Hemodynamic Parameters: cardiac output (L/min), pulmonary capillary wedge pressure (mmHg), pulmonary artery systolic and mean pressure (mmHg), right atrial pressure (mmHg).
- Echocardiographic Parameters: LVEF (%), mitral regurgitation grade (0-4), left atrial volume (mL /m2).
- Biological Parameters: Nt-proBNP (ng/L), Creatinine (µmol/L), GFR evaluate by Iohexol clearance (ml/min) or other method (ml/min) (inuline, EDTA chrome51 (51Cr EDTA), Iothalamate clearance),plasma volume calculated from haemoglobin (g/L) and haematocrit,(%) bilirubin (µmol/L), AST (UI/L), ALT (UI/L), kalemia (mmol/L), cystatin C (mg/L), sST2 (ng/mL), gremlins 1(pg/mL), FGF 23 (C terminal and intact) (pg/mL).
- Congestion Markers: Clinical, biological, echocardiographic, and hemodynamic markers.
Measured: 6 months of follow-up.
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: baseline and 12 months.
Global Leadership Initiative on Malnutrition criteria (GLIM Criteria)
To assess changes in nutritional status according to Global Leadership Initiative on Malnutrition criteria status between Baseline and 6 months. Categories : no malnutrition, moderate malnutrition, or severe malnutrition
Measured: baseline and 6 months
Daily food and nutrient intake
The food frequency questionnaire evaluate the frequency of consumption and portion size for 170 foods, we then calculate the daily food intake (in g/day). Nutritrional values are determined by converting food intake into nutrient intake using a french food composition table. Each item can have a minimum intake of 0, with quantities varying based on the specific food and individual consumption.
Measured: baseline or the month following baseline
cardiovascular death
To assess incidence of cardiac and renal adverse events.
Measured: 12 months
unplanned hospitalization for Heart failure
To assess incidence of cardiac and renal adverse events. The definition for unplanned heart failure hospitalization requires: 1) a hospital stay for worsening heart failure for >24 h; and 2) administration of intravenous or mechanical heart failure therapies, especially loop diuretics 3) heart failure symptoms/signs.
Measured: 12 months
worsening of Heart failure
To assess incidence of cardiac and renal adverse events. The definition for worsening of heart failure requires an administration of loop diuretics intravenous (ambulatory or home-care) due to a worsening of heart failure symptoms/signs.
Measured: 12 months
cardiac transplantation
To assess incidence of cardiac and renal adverse events
Measured: 12 months
ECMO
To assess incidence of cardiac and renal adverse events
Measured: 12 months
Left Ventricular Assist Device
To assess incidence of cardiac and renal adverse events
Measured: 12 months
Delisting from national waiting list
to assess incidence of cardiac and renal adverse events
Measured: 12 months
renal death
To assess incidence of cardiac and renal adverse events.
Measured: 12 months
chronic dialysis
To assess incidence of cardiac and renal adverse events.
Measured: 12 months
renal transplantation
To assess incidence of cardiac and renal adverse events.
Measured: 12 months
End stage renal disease
To assess incidence of cardiac and renal adverse events. Chronic dialysis, renal transplantation or sustained eGFR <15 mL/min/1.73m²
Measured: 12 months
worsening cardio-renal syndrome
To assess incidence of cardiac and renal adverse events. Worsening cardio-renal syndrome was defined according to the Kidney Disease Improving Global Outcomes (KIDGO) criteria as a ≥ 26.5 µmol/L (0.3mg/dL) increase in serum creatinine or 1.5-1.9 times baseline increase in serum creatinine or a urine output <0.5 ml/kg/h for 6-12 hours.
Measured: 12 months
GFR estimated by CKD-EPI formula (serum creatinine cystatin or both)
To assess the degree of agreement between the different methods of estimating GFR.
Measured: baseline and 6 months
GFR estimated by MDRD formula
To assess the degree of agreement between the different methods of estimating GFR.
Measured: baseline and 6 months
urinary creatinine (renal functional assessment (BFR))
To assess the degree of agreement between the different methods of estimating GFR.
Measured: baseline and 6 months
iohexol clearance
to assess the degree of agreement between the different methods of estimating GFR
Measured: baseline and 6 months
inuline clearance
To assess the degree of agreement between the different methods of estimating GFR
Measured: baseline and 6 months
EDTA chrome51
To assess the degree of agreement between the different methods of estimating GFR
Measured: baseline and 6 months
Iothalamate clearance
To assess the degree of agreement between the different methods of estimating GFR
Measured: baseline and 6 months
PLAUR gene expression
To assess the change in gene expression (including PLAUR gene) using the RNA collected at baseline and at 6 months.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start29 Aug 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion12 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BAUDRY Guillaume, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, MD-PhD, Study chair, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868797
- Sponsor's protocol ID
- 2023PI024
- Other IDs
- 2024-A02450-47
- Acronym
- ARCADIA-HF
- Status last verified
- Sep 2025
- First submitted
- 17 Feb 2025
- Last updated
- 11 Sep 2025
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
- ClinicalTrials.gov ID
- NCT06868797
- Acronym / sponsor ID
- ARCADIA-HF / 2023PI024
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 12 Sep 2027 (estimated)
- First posted
- 11 Mar 2025 (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.
Heart failure affects 1 to 2% of the adult population in developed countries, representing about 55 million people worldwide.
Advanced heart failure is a condition where the heart can no longer provide sufficient cardiac output or equilibrate pressures within its chambers, leading to symptoms such as shortness of breath, fatigue, and water and salt retention.
Heart failure affects the kidneys by reducing blood flow directed to them, sometimes leading to kidney congestion. In the long term, this can degrade kidney function. Common medications used to treat heart failure, such as diuretics, can sometimes worsen kidney failure. This link between the heart and the kidneys is known as cardio-renal syndrome and requires careful management of both organs to prevent mutual degradation.
Dapagliflozin is an SGLT2 inhibitor medication used to treat type 2 diabetes, heart failure, and certain kidney diseases. It helps reduce blood sugar, improve heart and kidney function, while promoting the elimination of excess salt and water.
However, there are limited data regarding the progression of cardio-renal interactions in patients with advanced heart failure. Yet, advanced heart failure is often associated with kidney dysfunction.
The protein called suPAR is found in the blood of patients developing kidney disease and/or during the onset of acute kidney injury. This protein will allow to characterize a population of patients with advanced heart failure receiving optimized medical treatment, including dapagliflozin.
The main objective of this research is to assess, based on the suPAR protein level in the blood, the progression of cardio-renal damage between inclusion and 6 months in patients with advanced heart failure who are listed for a heart transplant and treated with a therapy including dapagliflozin.
The study plans 5 visits over 12 months. The research will take place in the cardiology department of several French hospitals.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Patients followed for end-stage heart failure | Other | Other: Biological sample for the measurement of suPAR levels.Patients followed for end-stage heart failure and waiting for heart transplantation. This cohort will focus on cardio-renal assessment of advanced HF patients treated with optimal pharmacologic therapy including dapagliflozin. The biological material and clinical data collected will allow us to better understand the advanced HF and to generate new research hypotheses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and ≤ 85 years
- NYHA class ≥3
- LVEF ≤ 35%
- On GDMT (including dapagliflozin) based on current heart failure practice guidelines at maximal tolerated dose
- On waiting list (or on the registration pathway) for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant ≥ 6 months or in a pre-transplant pathway.
Key exclusion criteria (13 listed)
- Priority patient on waiting list for heart transplantation.
- Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.
- Inotrope dependent, existence of ongoing mechanical circulatory support
- Current acute decompensated HF or hospitalization due to decompensated HF <30 days prior to the enrolment.
- History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion.
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 |
|---|---|---|
| Biological sample for the measurement of suPAR levels.Biological sample for the measurement of plasminogen activator receptor (suPAR) level at baseline and at 6 months follow up to assess the evolution of cardio-renal interaction in HF patients listed for heart transplant treated by GDMT including dapagliflozin. | Other | Patients followed for end-stage heart failure |
Primary outcome
the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml)
Time frame: baseline and 6 months of follow-up.
the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml) between the baseline and 6 months of follow-up.
26 secondary outcomes
VO2 max
Time frame: baseline and 6 months of follow-up.
Delta GFR estimated by CKD-EPI formula (ml/min/1.73m²)
Time frame: baseline and 6 months of follow-up.
Rate of composite outcome (hospitalization for acute heart failure or all cause death).
Time frame: 6 months of follow-up.
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: baseline and 12 months.
Global Leadership Initiative on Malnutrition criteria (GLIM Criteria)
Time frame: baseline and 6 months
Daily food and nutrient intake
Time frame: baseline or the month following baseline
cardiovascular death
Time frame: 12 months
unplanned hospitalization for Heart failure
Time frame: 12 months
worsening of Heart failure
Time frame: 12 months
cardiac transplantation
Time frame: 12 months
ECMO
Time frame: 12 months
Left Ventricular Assist Device
Time frame: 12 months
Delisting from national waiting list
Time frame: 12 months
renal death
Time frame: 12 months
chronic dialysis
Time frame: 12 months
renal transplantation
Time frame: 12 months
End stage renal disease
Time frame: 12 months
worsening cardio-renal syndrome
Time frame: 12 months
GFR estimated by CKD-EPI formula (serum creatinine cystatin or both)
Time frame: baseline and 6 months
GFR estimated by MDRD formula
Time frame: baseline and 6 months
urinary creatinine (renal functional assessment (BFR))
Time frame: baseline and 6 months
iohexol clearance
Time frame: baseline and 6 months
inuline clearance
Time frame: baseline and 6 months
EDTA chrome51
Time frame: baseline and 6 months
Iothalamate clearance
Time frame: baseline and 6 months
PLAUR gene expression
Time frame: baseline and 6 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 11 Sep 2025.
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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.
Nicolas GIRERD, MD-PhD study chair
CHRU de NANCY
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sample for the measurement of suPAR levels. in people with Heart Failure, run by Central Hospital, Nancy, France at 11 sites in France.
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 13 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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 Guillaume BAUDRY, MD (+33 (0) 383157322, g.baudry@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml) (time frame: baseline and 6 months of follow-up.). 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 11 Sep 2025.