End-stage Heart FailurePhase 2ARCADIA-HFNCT04782245
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
A Phase 2 study testing Dapagliflozin 10mg in people with End-stage Heart Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In the DAPA-HF trial, the use of dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduced significantly the risk of worsening heart failure or death from cardiovascular causes compared to placebo among patients with heart failure (HF) and a reduced ejection fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Heart Failure
- What is being tested?
- Dapagliflozin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patient has signed informed consent form
- Age ≥ 18 years
- NYHA class ≥3
- LVEF ≤ 35%
- On optimal medical management (OMM) based on current heart failure practice guidelines at maximal tolerated dose for at least 30 days
- On waiting list for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant ≥ 6 months
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 randomization
- Presence of an active, uncontrolled infection
Show all 20Show fewer
- Any recent interventional procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) < 60 days
- Glomerular filtration rate < 30 ml/min/1.73 m2, according to CKD-EPI formula
- Unstable or rapidly progressing renal disease
- Patients with severe hepatic impairment (Child-Pugh class C)
- Chronic treatment with dapagliflozin or other SGLT2 inhibitors
- Patient with known history of severe drug intolerance to dapagliflozin or any excipients of the dapagliflozin (galactose, lactase)
- Type 1 diabetes mellitus
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or extraction of study drug at investigators' discretion
- Participation in another clinical interventional trial
- Any condition other than heart failure that could limit survival to less than 24 months
- Positive pregnancy test if of childbearing potential or refusal to use adequate contraception or women breast-feeding
- Patients with any legal protection measure
- Patients without any health coverage
- Psychiatric disease/disorder, irreversible cognitive dysfunction or psychological issues that are likely to impair compliance
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron, 69677
About this study
Official title: Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List: a Multicenter, Double-blind, Randomized Clinical Trial.
In the DAPA-HF trial, the use of dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduced significantly the risk of worsening heart failure or death from cardiovascular causes compared to placebo among patients with heart failure (HF) and a reduced ejection fraction. This new drug offers a very potent and interesting therapeutic pathway since it reduces clinical congestion, it preserves glomerular renal function, does not appear to cause symptomatic clinical hypotension and improves symptoms and quality of life compared to placebo.
Advanced heart failure patients with reduced ejection fraction represent a small and severe subgroup of heart failure of patients with frequent worsening heart failure events and high rates of death. The effect of dapagliflozin in this subgroup of patients was not assessed in the DAPA-HF study. The therapeutic profile of SGLT2 inhibitors appears to be of high interest, since this group of patients has a poor tolerance to usual heart failure drugs, frequent worsening renal function and congestive symptoms persistence with poor quality of life scores.
Read more
Soluble urokinase-type plasminogen activator receptor (suPAR) is a signaling glycoprotein considered to be involved in the pathogenesis of kidney disease. It is associated with the risk of acute kidney injury in different clinical and experimental situation. It is also a new validated biomarker predictive of adverse clinical outcome in heart failure patients. This biomarker allows a better risk stratification in heart failure patients after adjustment for Nt-proBNP.
As a useful biomarker implicated in both heart failure and acute kidney injury, suPAR seems to be an interesting biomarker to assess cardio-renal benefits of dapagliflozin.
The aim of this study is to investigate if a treatment by dapagliflozin reduces significantly suPAR compared to placebo in a population of advanced heart failure patients, candidates to heart transplantation. The effect of dapagliflozin compared to placebo will also be assessed on other secondary heart failure outcomes in this patient population.
- Conditions
- End-stage Heart Failure
- Being tested
- Dapagliflozin 10mg, Placebo
- Keywords
- End-stage heart failure,, Cardio-renal syndrome, Dapagliflozin
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mgDrug
The intervention group will receive, during 6 months, dapagliflozin per oral route at a dose of 10 mg once daily in addition to the optimal medical management based on current heart failure practice guidelines.
PlaceboDrug
Patients randomized in the control group will receive during 6 months, placebo once daily per oral route, in addition to the optimal medical management based on current heart failure practice guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group Daplagliflozin | Experimental | Not described Receives: Drug: Dapagliflozin 10mg |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of suPAR (ng/ml)
Measured: 6 months
Secondary outcomes (14)
VO2 max assessment
VO2 max assessment to evaluate the functional status
Measured: 6 months
cardiac output assessed by right heart catheterization
The impact of dapagliflozin on hemodynamic parameters between baseline and 6 months assessed by right heart catheterization hemodynamic parameters
Measured: 6 months
pulmonary capillary wedge pressure assessed by right heart catheterization
The impact of dapagliflozin on hemodynamic parameters between baseline and 6 months assessed by right heart catheterization hemodynamic parameters
Measured: 6 months
pulmonary artery systolic and mean pressure assessed by right heart catheterization
The impact of dapagliflozin on hemodynamic parameters between baseline and 6 months assessed by right heart catheterization hemodynamic parameters
Measured: 6 months
mean pressure assessed by right heart catheterization
The impact of dapagliflozin on hemodynamic parameters between baseline and 6 months assessed by right heart catheterization hemodynamic parameters
Measured: 6 months
right atrial pressure assessed by right heart catheterization
The impact of dapagliflozin on hemodynamic parameters between baseline and 6 months assessed by right heart catheterization hemodynamic parameters
Measured: 6 months
Left Ventricular Ejection Function assessed by echocardiography
The impact of dapagliflozin on echocardiographic parameters between baseline and 6 months
Measured: 6 months
Left ventricular end-diastolic diameter assessed by echocardiography
The impact of dapagliflozin on echocardiographic parameters between baseline and 6 months
Measured: 6 months
Left ventricular end systolic volume assessed by echocardiography
The impact of dapagliflozin on echocardiographic parameters between baseline and 6 months
Measured: 6 months
mitral regurgitation grade assessed by echocardiography
The impact of dapagliflozin on echocardiographic parameters between baseline and 6 months
Measured: 6 months
left atrial volume assessed by echocardiography
The impact of dapagliflozin on echocardiographic parameters between baseline and 6 months
Measured: 6 months
Nt-proBNP level
Measured: 6 months
Creatinine level
Measured: 6 months
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study startSep 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: New recommandations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BAUDRY, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782245
- Sponsor's protocol ID
- 69HCL20_1135
- Other IDs
- 2020-005713-40
- Acronym
- ARCADIA-HF
- Status last verified
- Aug 2023
- First submitted
- 1 Mar 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. 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: a Multicenter, Double-blind, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04782245
- Acronym / sponsor ID
- ARCADIA-HF / 69HCL20_1135
- Conditions
- End-stage Heart Failure
- Keywords
- End-stage heart failure,, Cardio-renal syndrome, Dapagliflozin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New recommandations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 4 Mar 2021 (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.
In the DAPA-HF trial, the use of dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduced significantly the risk of worsening heart failure or death from cardiovascular causes compared to placebo among patients with heart failure (HF) and a reduced ejection fraction. This new drug offers a very potent and interesting therapeutic pathway since it reduces clinical congestion, it preserves glomerular renal function, does not appear to cause symptomatic clinical hypotension and improves symptoms and quality of life compared to placebo.
Advanced heart failure patients with reduced ejection fraction represent a small and severe subgroup of heart failure of patients with frequent worsening heart failure events and high rates of death. The effect of dapagliflozin in this subgroup of patients was not assessed in the DAPA-HF study. The therapeutic profile of SGLT2 inhibitors appears to be of high interest, since this group of patients has a poor tolerance to usual heart failure drugs, frequent worsening renal function and congestive symptoms persistence with poor quality of life scores.
Soluble urokinase-type plasminogen activator receptor (suPAR) is a signaling glycoprotein considered to be involved in the pathogenesis of kidney disease. It is associated with the risk of acute kidney injury in different clinical and experimental situation. It is also a new validated biomarker predictive of adverse clinical outcome in heart failure patients. This biomarker allows a better risk stratification in heart failure patients after adjustment for Nt-proBNP.
As a useful biomarker implicated in both heart failure and acute kidney injury, suPAR seems to be an interesting biomarker to assess cardio-renal benefits of dapagliflozin.
The aim of this study is to investigate if a treatment by dapagliflozin reduces significantly suPAR compared to placebo in a population of advanced heart failure patients, candidates to heart transplantation. The effect of dapagliflozin compared to placebo will also be assessed on other secondary heart failure outcomes in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group Daplagliflozin | Experimental | Drug: Dapagliflozin 10mg |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has signed informed consent form
- Age ≥ 18 years
- NYHA class ≥3
- LVEF ≤ 35%
- On optimal medical management (OMM) based on current heart failure practice guidelines at maximal tolerated dose for at least 30 days
Key exclusion criteria (20 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 randomization
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 |
|---|---|---|
| Dapagliflozin 10mgThe intervention group will receive, during 6 months, dapagliflozin per oral route at a dose of 10 mg once daily in addition to the optimal medical management based on current heart failure practice guidelines. | Drug | Treatment group Daplagliflozin |
| PlaceboPatients randomized in the control group will receive during 6 months, placebo once daily per oral route, in addition to the optimal medical management based on current heart failure practice guidelines. | Drug | Control group |
Primary outcome
Levels of suPAR (ng/ml)
Time frame: 6 months
14 secondary outcomes
VO2 max assessment
Time frame: 6 months
cardiac output assessed by right heart catheterization
Time frame: 6 months
pulmonary capillary wedge pressure assessed by right heart catheterization
Time frame: 6 months
pulmonary artery systolic and mean pressure assessed by right heart catheterization
Time frame: 6 months
mean pressure assessed by right heart catheterization
Time frame: 6 months
right atrial pressure assessed by right heart catheterization
Time frame: 6 months
Left Ventricular Ejection Function assessed by echocardiography
Time frame: 6 months
Left ventricular end-diastolic diameter assessed by echocardiography
Time frame: 6 months
Left ventricular end systolic volume assessed by echocardiography
Time frame: 6 months
mitral regurgitation grade assessed by echocardiography
Time frame: 6 months
left atrial volume assessed by echocardiography
Time frame: 6 months
Nt-proBNP level
Time frame: 6 months
Creatinine level
Time frame: 6 months
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for End-stage Heart Failure
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Active, not recruitingPhase 3
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
RecruitingPhase 2/3
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
End Stage Kidney Disease
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. This study is not recruiting at the moment.
Guillaume BAUDRY, Dr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10mg in people with End-stage Heart Failure, run by Hospices Civils de Lyon at 1 site 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 6 inclusion and 20 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: withdrawn, as of the sponsor's last update on 7 Aug 2023. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of suPAR (ng/ml) (time frame: 6 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 7 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.