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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 Clínico de Valencia