Heart FailurePhase 4NCT06578520
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
A Phase 4 study testing Dapagliflozin in people with Heart Failure, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study. 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?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jul 2024to 31 Dec 2026
- Phase
- Phase 4
- 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
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Provision of informed consent form prior to any study specific procedures, sampling and analysis.
- Individuals must be ≥ 18 years of age at the time of signing the informed consent
- Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).
- In treatment with Peritoneal Dialysis technique
- Chronic Kidney Disease (eGFR < 60 ml/min/m2 CKD-EPI formula)
Show all 10Show fewer
- PD vintage of more than 30 days
- On stable doses of furosemide, or alternative loop diuretic for 14 days
- On stable HF therapy for at least 1 month prior to consent
- No hospitalizations for HF for at least 1 month prior to consent
Who cannot join
- Limited life expectancy (less than 1 year) based on investigator's clinical judgement.
- Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information.
- Malignancy (with active treatment) or other life-threatening disease
- Patients in whom proper study compliance cannot be guaranteed
- Rejection or revocation of informed consent
- Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 1 month prior to enrollment.
Show all 18Show fewer
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement) within 1 month prior to enrollment or planned to undergo any of these operations after randomization.
- Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 1 month prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
- Pregnant or breast-feeding women
- Type 1 Diabetes
- Residual urine volume less than 500ml daily or reduction in urinary output by 24 hours (< 30% compared to previous routine control) within 30 days prior to consent
- Patients with amputated limbs will be excluded of bioimpedance analysis.
- Participation in another clinical study with an investigational product during the last 3 months.
- Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product.
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
- Previous enrolment in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Use of Dapagliflozin in Diuresis, Natriuresis and in Ultrafiltration and Peritoneal Elimination of Sodium, in Patients With Refractory Heart Failure
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
Read the detailed description
Peritoneal dialysis (PD) is a technique that has been successfully used for the treatment of refractory heart failure to diuretics. In patients on PD, the harmful effects of sodium retention become even greater, resulting in fluid overload, hypertension and left ventricular hypertrophy in more than half of the PD population. This is due to the fact that the accumulation of sodium in the skin interstitium would generate an inflammatory environment and, therefore, the activation of growth and fibrogenic factors with a consequent increase in cardiac muscle mass.
In patients with HF receiving PD, therefore, it is necessary to reduce salt intake with diet, as well as to ensure adequate elimination through available medical treatments and elimination of Na through the most appropriate dialysis technique.
In recent years, a new player has joined the treatment of HF: iSGLT2, an oral hypoglycaemic drug. ISGLT2 promotes natriuresis thanks to its well-known mechanism of inhibition of Na and glucose co-transporter. Also promoting excretion of Na at the distal tubule level due to increased tubular osmotic pressure secondary to glycosuria, as well as by direct inhibition of NH3 channels reabsorbing Na and Hydrogens.
The purpose of the study is to analyse whether the use of an SGLT2 inhibitor (Dapagliflozin) in patients with CKD and HF treated with peritoneal dialysis can benefit patients in terms of increased total elimination of sodium and water.
In this study, dapagliflozin will be used together with established drug therapy for patients with HF, including concomitant diuretic therapy.
after randomization, the patient will be divided in two groups and they will receive the study drug or placebo for 8 weeks and, after a 4-week wash out, each patient will switch groups for further 8 weeks to receive standard of care or standard of care plus Dapaglifozin as appropriate.
The study will end with a safety extension study in which all patients will take Dapagliflozin for a further 8 weeks.
- Conditions
- Heart Failure
- Being tested
- Dapagliflozin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
10 mg once per day, oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | They will receive standard of care plus Dapaglifozin for 8 weeks, after a 4-week wash out, they will receive receive standard of care for another 8 weeks. Receives: Drug: Dapagliflozin |
| Group 2 | Experimental | They will receive standard of care for 8 weeks, after a 4-week wash out, they will receive receive standard of care for another 8 weeks plus Dapaglifozin. Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 3rd (8th week) visit control compared with the 6th (20th week)visit control.
To explore the effect of iSGLT2 in natriuresis and the peritoneal elimination of sodium in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Secondary outcomes (9)
Mean difference of the sum between the volume of diuresis in 24 hours and the daily peritoneal effluent ultrafiltration rate (ml/24hours) in the 3rd (8th week) visit control compared with the 6th (20th week) visit control.
To explore the effect of the use of iSGLT2 in diuresis and, in the peritoneal net ultrafiltration in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Mean difference of the sum between the volume of diuresis in 24 hours and the daily peritoneal effluent ultrafiltration rate (ml/24hours) in the 2nd (4th week) visit control compared with the 5th (16th week) visit control.
To explore the effect of the use of iSGLT2 in diuresis and, in the peritoneal net ultrafiltration in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 2nd visit control compared with the 5th visit control.
To explore the effect of iSGLT2 in natriuresis and the peritoneal elimination of sodium in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Mean difference between the hydration percentage: Total Body Water%, Extracellular Water% , Intracellular Water%, Plasma Fluid, Interstitial Fluid by bioimpedance in the 3rd visit control compared with the 6th visit control.
To explore the effect of the use of iSGLT2 in the normalization of extracellular volume in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Collection of chemistry parameters: Mean change and standard deviations in Peritoneal Fluid Glucose Ratio and Sodium concentration in the effluent peritoneal dialysis fluid sample in the 3rd visit control compared with the 6th visit control.
To evaluate the effect of the use of iSGLT2 in Glucose and sodium homeostasis in the peritoneal fluid effluent in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Mean change and standard deviations in Peritoneal Fluid Glucose Ratio (D4/D0) and Sodium (mEq/24hr) concentration in the effluent peritoneal dialysis fluid sample in the 2nd visit control compared with the 5th visit control.
To evaluate the effect of the use of iSGLT2 in Glucose and sodium homeostasis in the peritoneal fluid effluent in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Mean Difference in NYHA Classification, Ultrasounds parameters for the evaluation of venous congestion and BNP (ng/ml), CA 125 (ng/ml) in the blood sample in the 3rd visit control compared with the 6th visit control.
To evaluate the effect of the use of iSGLT2 in the clinical and laboratory parameters in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Mean difference in Ca125 (U/min), IL-6 (pg/min), in the effluent peritoneal dialysis fluid sample in the 3rd visit control compared with the 6th visit control.
To study the effect of the use of iSGLT2 in the inflammatory state of the peritoneal membrane in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Mean Change in the total amount of loop diuretic and thiazide treatment (mg/daily) in the 3rd visit control compared with the 6th visit control.
To evaluate the effect of the use of iSGLT2 in dose reduction of diuretics and the need for diuretic therapy in patients with CKD and refractory HF treated with peritoneal dialysis.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start30 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, open-label, crossover study, parallel, 2-sequence, 2-period, 2-treatment.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Montomoli, Principal investigator, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578520
- Sponsor's protocol ID
- DAPA-DP
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Dapagliflozin in Diuresis, Natriuresis and in Ultrafiltration and Peritoneal Elimination of Sodium, in Patients With Refractory Heart Failure
- ClinicalTrials.gov ID
- NCT06578520
- Acronym / sponsor ID
- DAPA-DP
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Aug 2024 (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.
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
Detailed description
Peritoneal dialysis (PD) is a technique that has been successfully used for the treatment of refractory heart failure to diuretics. In patients on PD, the harmful effects of sodium retention become even greater, resulting in fluid overload, hypertension and left ventricular hypertrophy in more than half of the PD population. This is due to the fact that the accumulation of sodium in the skin interstitium would generate an inflammatory environment and, therefore, the activation of growth and fibrogenic factors with a consequent increase in cardiac muscle mass.
In patients with HF receiving PD, therefore, it is necessary to reduce salt intake with diet, as well as to ensure adequate elimination through available medical treatments and elimination of Na through the most appropriate dialysis technique.
In recent years, a new player has joined the treatment of HF: iSGLT2, an oral hypoglycaemic drug. ISGLT2 promotes natriuresis thanks to its well-known mechanism of inhibition of Na and glucose co-transporter. Also promoting excretion of Na at the distal tubule level due to increased tubular osmotic pressure secondary to glycosuria, as well as by direct inhibition of NH3 channels reabsorbing Na and Hydrogens.
The purpose of the study is to analyse whether the use of an SGLT2 inhibitor (Dapagliflozin) in patients with CKD and HF treated with peritoneal dialysis can benefit patients in terms of increased total elimination of sodium and water.
In this study, dapagliflozin will be used together with established drug therapy for patients with HF, including concomitant diuretic therapy.
after randomization, the patient will be divided in two groups and they will receive the study drug or placebo for 8 weeks and, after a 4-week wash out, each patient will switch groups for further 8 weeks to receive standard of care or standard of care plus Dapaglifozin as appropriate.
The study will end with a safety extension study in which all patients will take Dapagliflozin for a further 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-label, crossover study, parallel, 2-sequence, 2-period, 2-treatment.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: DapagliflozinThey will receive standard of care plus Dapaglifozin for 8 weeks, after a 4-week wash out, they will receive receive standard of care for another 8 weeks. |
| Group 2 | Experimental | Drug: DapagliflozinThey will receive standard of care for 8 weeks, after a 4-week wash out, they will receive receive standard of care for another 8 weeks plus Dapaglifozin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Provision of informed consent form prior to any study specific procedures, sampling and analysis.
- Individuals must be ≥ 18 years of age at the time of signing the informed consent
- Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).
- In treatment with Peritoneal Dialysis technique
Key exclusion criteria (18 listed)
- Limited life expectancy (less than 1 year) based on investigator's clinical judgement.
- Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information.
- Malignancy (with active treatment) or other life-threatening disease
- Patients in whom proper study compliance cannot be guaranteed
- Rejection or revocation of informed consent
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 |
|---|---|---|
| DapagliflozinAlso: Forxiga10 mg once per day, oral tablets | Drug | Group 1, Group 2 |
Primary outcome
Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 3rd (8th week) visit control compared with the 6th (20th week)visit control.
Time frame: Through study completion, an average of 4 months
To explore the effect of iSGLT2 in natriuresis and the peritoneal elimination of sodium in patients with CKD and refractory HF treated with peritoneal dialysis.
9 secondary outcomes
Mean difference of the sum between the volume of diuresis in 24 hours and the daily peritoneal effluent ultrafiltration rate (ml/24hours) in the 3rd (8th week) visit control compared with the 6th (20th week) visit control.
Time frame: Through study completion, an average of 4 months
Mean difference of the sum between the volume of diuresis in 24 hours and the daily peritoneal effluent ultrafiltration rate (ml/24hours) in the 2nd (4th week) visit control compared with the 5th (16th week) visit control.
Time frame: Through study completion, an average of 4 months
Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 2nd visit control compared with the 5th visit control.
Time frame: Through study completion, an average of 4 months
Mean difference between the hydration percentage: Total Body Water%, Extracellular Water% , Intracellular Water%, Plasma Fluid, Interstitial Fluid by bioimpedance in the 3rd visit control compared with the 6th visit control.
Time frame: Through study completion, an average of 4 months
Collection of chemistry parameters: Mean change and standard deviations in Peritoneal Fluid Glucose Ratio and Sodium concentration in the effluent peritoneal dialysis fluid sample in the 3rd visit control compared with the 6th visit control.
Time frame: Through study completion, an average of 4 months
Mean change and standard deviations in Peritoneal Fluid Glucose Ratio (D4/D0) and Sodium (mEq/24hr) concentration in the effluent peritoneal dialysis fluid sample in the 2nd visit control compared with the 5th visit control.
Time frame: Through study completion, an average of 4 months
Mean Difference in NYHA Classification, Ultrasounds parameters for the evaluation of venous congestion and BNP (ng/ml), CA 125 (ng/ml) in the blood sample in the 3rd visit control compared with the 6th visit control.
Time frame: Through study completion, an average of 4 months
Mean difference in Ca125 (U/min), IL-6 (pg/min), in the effluent peritoneal dialysis fluid sample in the 3rd visit control compared with the 6th visit control.
Time frame: Through study completion, an average of 4 months
Mean Change in the total amount of loop diuretic and thiazide treatment (mg/daily) in the 3rd visit control compared with the 6th visit control.
Time frame: Through study completion, an average of 4 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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marco Montomoli principal investigator
Hospital Clínico Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Heart Failure, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
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 10 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 3rd (8th week) visit control compared with the 6th (20th week)visit control. (time frame: Through study completion, an average of 4 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 9 Sep 2026.