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Active Not Recruiting NCT06578520

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

Conditions: Heart Failure

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 31
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Location: Hospital Clínico Universitario de Valencia Valencia

Summary

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

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06578520). StuddyBuddy aggregates publicly available trial information.