Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure (NCT06578520) | Clinical Trial Compass
RecruitingPhase 4
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Spain31 participantsStarted 2024-07-30
Plain-language summary
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 enrollme…
What they're measuring
1
Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 3rd (8th week) visit control compared with the 6th (20th week)visit control.
Timeframe: Through study completion, an average of 4 months
Trial details
NCT IDNCT06578520
SponsorFundación para la Investigación del Hospital ClÃnico de Valencia