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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)
EU CTIS ID: 2023-505571-78-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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
You likely can't join if
- 1. 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.