Status:
RECRUITING
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06578520
Start Date
July 30 2024
End Date
December 31 2025
Last Update
August 6 2025
Active Locations (1)
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1
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010