To assess the efficacy of oral treatment with dapagliflozin to reduce suPAR compared to placebo in advanced heart failure patients on heart transplant list at 6 months of follow-up.

Phase 1

• Conditions: for advanced Heart Failure patients on heart transplant waiting list; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005713-40-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-27
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1)Patient has signed informed consent form
2)Age = 18 years
3)NYHA class =3
4)LVEF = 35%
5)On optimal medical management (OMM) based on current heart failure practice guidelines at maximal tolerated dose for at least 30 days
6)On waiting list for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant = 6 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1)Priority patient on waiting list for heart transplantation
2)Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
3)Inotrope dependent, existence of ongoing mechanical circulatory support
4)Current acute decompensated HF or hospitalization due to decompensated HF <30 days prior to the enrolment
5)History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization
6)Presence of an active, uncontrolled infection
7)Any recent interventional procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) < 60 days
8)Glomerular filtration rate < 30 ml/min/1.73 m2, according to CKD-EPI formula
9)Unstable or rapidly progressing renal disease
10)Patients with severe hepatic impairment (Child-Pugh class C)
11)Chronic treatment with dapagliflozin or other SGLT2 inhibitors
12)Patient with known history of severe drug intolerance to dapagliflozin or any excipients of the dapagliflozin (galactose, lactase)
13)Type 1 diabetes mellitus
14)Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or extraction of study drug at investigators’ discretion
15)Participation in another clinical interventional trial
16)Any condition other than heart failure that could limit survival to less than 24 months
17)Positive pregnancy test if of childbearing potential or refusal to use adequate contraception or women breast-feeding
18)Patients with any legal protection measure
19)Patients without any health coverage
20)Psychiatric disease/disorder, irreversible cognitive dysfunction or psychological issues that are likely to impair compliance

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified