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

Summary

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

Eligibility

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.

Conditions2

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