Hepato-renal Regulation of Water Conservation in Heart Failure Patients With SGLT-2 Inhibitor Treatment

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effects of Dapagliflozin (FORXIGA) 10mg (n=20) and placebo (n=20) on the renal concentration mechanism, mobilization of Na+ from tissue stores, and mobilization of muscle glycogen and fat, in patients heart failure NYHA classes I and II,with or w/o T2DM in a 4-week double-blind, placebo-controlled, randomized study with 2 treatment arms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart Centre Singapore
• Collaborator: Duke-NUS Medical School (Singapore)
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors

Criteria

Inclusion Criteria:

1. Diagnosis of heart failure NYHA stage I or II - as shown by their medical records

2. Stable anti-hypertensive treatment (>4 weeks)

3. Male and female patients older than 21 years

4. Willingness to participate and ability to provide informed consent

5. Willingness to use effective birth control if of childbearing potential. Any kind of contraception method will be allowed for the period of the study

Exclusion Criteria:

1. Patients with congestive heart failure NYHA stages I (LVEF >40%) without type 2 diabetes mellitus.

2. Patients with congestive heart failure NYHA stages III and IV

3. Prior serious hypersensitivity reaction to Dapagliflozin (Forxiga®)

4. Treatment with any SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitors within 1 week prior to Visit 1 or during screening period until Visit 1

5. Pregnant and breast-feeding women

6. Diagnosis of type 1 diabetes mellitus

7. Patients with type 2 diabetes mellitus with HbA1C > 10.5% from most recent medical records or antidiabetic therapies other than metformin, sulfonylureas or gliptins at screening.

8. Patients with type 2 diabetes mellitus whose antidiabetic treatment (metformin and/or sulfonylureas and/or gliptins) has been changed or unstable within 6 weeks prior to Visit 1

9. . Unstable or rapidly progressing renal disease

10. Chronic cystitis and recurrent urinary tract infections

11. Impaired renal function with eGFR<45 ml/min/1.73m2 or proteinuria > 0.5 g/24h

12. Severe hepatic impairment (Child-Pugh class C)

13. Any major cardiovascular event/vascular disease within 3 months prior to enrolment, as assessed by the investigator

14. Severe edema (as judged by the investigator)

15. Active cancer, history of bladder cancer

16. HIV infection

17. Patients who have received an organ or bone marrow transplant

18. Patients who have had major surgery in the past 3 months

19. Patients who have severe comorbid conditions likely to compromise survival or study participation

20. Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MRI scanner

21. Patients with exclusion criteria for the MRI, such as:

1. implanted devices (surgical clips, heart pacemakers or defibrillators, cochlear implants)

2. iron-based tattoos

3. any other pieces of metal or devices that are not MR-Safe anywhere in the body

22. Unwillingness or other inability to cooperate