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DAPARHT: DAPAgliflozin for Renal protection in Heart Transplant recipients
EU CTIS ID: 2023-506486-60-01
What this study is testing
The main goal of the DAPARHT trial is to evaluate the effect of dapagliflozin on renal function in cardiac allograft recipients
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Heart transplant recipient for ≥ 1 year
- Age ≥ 18 years
- Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations
- Estimated glomerular filtration rate ≥ 25 ml/min/1.73 m2 as assessed by the MDRD formula
- The subject is, in the opinion of the Investigator, clinically suitable for randomisation to dapagliflozin/placebo
You likely can't join if
- Contraindications to study medication
- Breastfeeding
- Female subject who has either (1) not used at least one highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilised or postmenopausal
- Estimated GFR < 25 ml/min/m2
- Type 1 diabetes
- Severe liver failure (Child-Pugh’s score C)
See the full eligibility criteria
- Heart transplant recipient for ≥ 1 year
- Age ≥ 18 years
- Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations
- Estimated glomerular filtration rate ≥ 25 ml/min/1.73 m2 as assessed by the MDRD formula
- The subject is, in the opinion of the Investigator, clinically suitable for randomisation to dapagliflozin/placebo
- Contraindications to study medication
- Breastfeeding
- Female subject who has either (1) not used at least one highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilised or postmenopausal
- Estimated GFR < 25 ml/min/m2
- Type 1 diabetes
- Severe liver failure (Child-Pugh’s score C)
- Life expectancy reduced to < 2 years as judged by the investigator
- Unresolved malignant disease
- Failure to obtain written informed consent
- SGL2 inhibitor treatment over the four weeks prior to randomisation
- Pregnancy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.