DAPARHT: DAPAgliflozin for Renal protection in Heart Transplant recipients

Phase 3

Conditions: Cardiac Failure
Renal dysfunction
10019280
10038430

Registration Number: NL-OMON51463

Lead Sponsor: Oslo University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

1. Heart transplant recipient >= 1 year after heart transplant.
2. Age >= 18 years

Exclusion Criteria

1. Contraindications to study medication.
2. Estimated GFR < 25 ml/min/m2
3. Type I diabetes
4. Severe liver failure (Child-Pugh*s score C)
5. Life expectancy reduced to < 2 years as judged by the investigator
6. Unresolved malignant disease
7. Failure to obtain written informed consent
8. SGL2 inhibitor treatment over the last month
9. Pregnancy
10. Breast-feeding
11. Woman of child-bearing potential who is not willing to use a highly
effective method of birth control

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: The chronic slope of the eGFR from 2 weeks to<br /><br>end-of-treatment (12 months).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>1. Change in body weight<br /><br>2. The change in the albumin/creatinine ratio in the urine from baseline to<br /><br>end-of-treatment in patients with a baseline ratio > 30 mg/g at baseline<br /><br>3. The change in the blood level of glycated haemoglobin (HbA1c) in patients<br /><br>with diabetes mellitus</p><br>