RecruitingPhase 4NCT06578520

Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure

Effect of the Use of Dapagliflozin in Diuresis, Natriuresis and in Ultrafiltration and Peritoneal Elimination of Sodium, in Patients With Refractory Heart Failure

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Enrollment

31 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure

Summary

Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria18

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.