Using Dapagliflozin for Patients with Heart Failure on Peritoneal Dialysis
Effect of the Use of Dapagliflozin in Diuresis, Natriuresis and in Ultrafiltration and Peritoneal Elimination of Sodium, in Patients With Refractory Heart Failure
This study is testing if the medication Dapagliflozin can help people with heart failure who are on peritoneal dialysis get rid of extra fluid and improve their heart health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT06578520 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Dapagliflozin, an SGLT2 inhibitor, on patients with heart failure who are undergoing peritoneal dialysis. It is a randomized, open-label, phase IV study designed to assess whether Dapagliflozin can enhance sodium and water elimination in these patients. The study will involve a cross-over design with two treatment periods, allowing for direct comparison of outcomes. Participants will be monitored for changes in fluid overload and related cardiovascular health metrics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of heart failure and chronic kidney disease who are currently receiving peritoneal dialysis.
Not a fit: Patients with a limited life expectancy of less than one year, as determined by the investigator, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve fluid management and overall heart function in patients with refractory heart failure on peritoneal dialysis.
How similar studies have performed: While the use of SGLT2 inhibitors in heart failure is gaining attention, this specific application in patients on peritoneal dialysis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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. * 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.
Where this trial is running
Valencia
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Marco Montomoli — Hospital Clínico Universitario de Valencia
- Study coordinator: Marco Montomoli
- Email: marcomontomoli@hotmail.it
- Phone: 961 973500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.