Actively Recruiting
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2025-08-06
31
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
CONDITIONS
Official Title
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent and comply with study requirements
- Age 18 years or older at time of consent
- Confirmed diagnosis of heart failure (NYHA class I-III, with reduced or preserved ejection fraction)
- Currently treated with peritoneal dialysis
- Chronic kidney disease with eGFR less than 60 ml/min/1.73 m2
- On peritoneal dialysis for more than 30 days
- Stable dose of furosemide or other loop diuretic for at least 14 days
- Stable heart failure therapy for at least 1 month prior to consent
- No hospitalizations for heart failure in the month before consent
You will not qualify if you...
- Life expectancy less than 1 year per investigator judgment
- No indication for dapagliflozin treatment according to approved guidelines
- Active cancer or other life-threatening illnesses
- Unable to comply with study procedures
- Declined or withdrew consent
- Acute heart failure, recent hospitalization for heart failure, heart attack, unstable angina, stroke, or transient ischemic attack within 1 month prior to enrollment
- Recent coronary revascularization or planned heart surgery within 1 month
- Cardiac resynchronization or defibrillator device implanted within 1 month or planned atrial fibrillation ablation or device implantation
- Previous cardiac transplant or ventricular assist device implantation or planned transplant/device
- Pregnant or breastfeeding women
- Type 1 diabetes diagnosis
- Urine output less than 500 ml daily or significant recent decrease in urine output
- Limb amputation preventing bioimpedance analysis
- Participation in another investigational study within last 3 months
- Known allergy to dapagliflozin or its ingredients
- Involved in planning or conducting this study
- Investigator judgment of likely noncompliance
- Prior enrollment in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
M
Marco Montomoli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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