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2023-505571-78-00RecruitingPhase 4

EFFECT OF THE USE OF DAPAGLIFLOZIN IN DIURESIS, NATRIURIESIS AND IN ULTRAFILTRATION AND PERITONEAL ELIMINATION OF SODIUM, IN PATIENTS WITH REFRACTORY HEART FAILURE (DAPA-DP study)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Next steps

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1 (estimated)
First submitted
27 Jun 2023
Start date
16 May 2024
Lead sponsor
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA
EU CT number
2023-505571-78-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 1
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart failure and chronic kidney disease who are on peritoneal dialysis. It studies the effect of dapagliflozin on sodium removal.

Age
18 years or older
Sex
All
Disease stage
Confirmed heart failure, NYHA class I-III (HFrEF or HFpEF). Chronic kidney disease with eGFR < 60 ml/min/m2. On peritoneal dialysis for more than 30 days.
Earlier treatment
Stable dose of furosemide or another loop diuretic for 14 days. Stable heart failure treatment for at least 1 month. No hospital stay for heart failure in the last month.
Biomarker or test result
eGFR < 60 ml/min/m2 (CKD-EPI formula)

Main reasons for not taking part

  • Life expectancy of less than 1 year
  • Type 1 diabetes
  • Pregnant or breast-feeding women
  • Heart attack, stroke or hospital stay for decompensated heart failure within the last month
  • Residual urine volume under 500ml daily

This trial only enrols participants on dialysis. The registry sentence this rests on: 5. In treatment with Peritoneal Dialysis technique

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Limited life expectancy (less than 1 year) based on investigator’s clinical judgement. 2. Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information. 3. Malignancy (with active treatment) or other life-threatening disease 4. Patients in whom proper study compliance cannot be guaranteed 5. Rejection or revocation of informed consent 6. Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 1 month prior to enrollment. 7. 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. 8. 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. 9. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization 10. Pregnant or breast-feeding women 11. Type 1 Diabetes 12. 9. 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 13. Patients with amputated limbs will be excluded of bioimpedance analysis. 14. Participation in another clinical study with an investigational product during the last 3 months. 15. Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product. 16. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site). 17. 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. 18. Previous enrolment in the present study.

Who the study is looking for

  • 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. 2. Provision of informed consent form prior to any study specific procedures, sampling and analysis. 3. Individuals must be ≥ 18 years of age at the time of signing the informed consent 4. Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF). 5. In treatment with Peritoneal Dialysis technique 6. Chronic Kidney Disease (eGFR < 60 ml/min/m2 CKD-EPI formula) 7. PD vintage of more than 30 days 8. On stable doses of furosemide, or alternative loop diuretic for 14 days 9. On stable HF therapy for at least 1 month prior to consent 10. No hospitalizations for HF for at least 1 month prior to consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVAValenciaSpainRecruiting

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