Effect of the use of dapagliflozin in diuresis, natriuresis and in ultrafiltration and peritoneal elimination of sodium, in patients with refractory heart failure
NCT ID NCT06578520
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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31 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
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Other studies related to the condition(s) this trial covers.
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