Status:
COMPLETED
Hepato-renal Regulation of Water Conservation in Heart Failure Patients With SGLT-2 Inhibitor Treatment
Lead Sponsor:
National Heart Centre Singapore
Collaborating Sponsors:
Duke-NUS Graduate Medical School
Conditions:
Diabetes Mellitus
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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 mobi...
Detailed Description
Sodium-glucose co-transporter-2 (SGLT-2) inhibitors are a new class of oral medications used for T2DM, which lower blood glucose levels by increasing renal sodium (Na+) and glucose excretion. However,...
Eligibility Criteria
Inclusion
- Diagnosis of heart failure NYHA stage I or II - as shown by their medical records
- Stable anti-hypertensive treatment (\>4 weeks)
- Male and female patients older than 21 years
- Willingness to participate and ability to provide informed consent
- 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
- Patients with congestive heart failure NYHA stages I (LVEF \>40%) without type 2 diabetes mellitus.
- Patients with congestive heart failure NYHA stages III and IV
- Prior serious hypersensitivity reaction to Dapagliflozin (Forxiga®)
- 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
- Pregnant and breast-feeding women
- Diagnosis of type 1 diabetes mellitus
- 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.
- 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
- . Unstable or rapidly progressing renal disease
- Chronic cystitis and recurrent urinary tract infections
- Impaired renal function with eGFR\<45 ml/min/1.73m2 or proteinuria \> 0.5 g/24h
- Severe hepatic impairment (Child-Pugh class C)
- Any major cardiovascular event/vascular disease within 3 months prior to enrolment, as assessed by the investigator
- Severe edema (as judged by the investigator)
- Active cancer, history of bladder cancer
- HIV infection
- Patients who have received an organ or bone marrow transplant
- Patients who have had major surgery in the past 3 months
- Patients who have severe comorbid conditions likely to compromise survival or study participation
- Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MRI scanner
- Patients with exclusion criteria for the MRI, such as:
- implanted devices (surgical clips, heart pacemakers or defibrillators, cochlear implants)
- iron-based tattoos
- any other pieces of metal or devices that are not MR-Safe anywhere in the body
- Unwillingness or other inability to cooperate
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04080518
Start Date
November 11 2019
End Date
November 10 2021
Last Update
April 13 2023
Active Locations (1)
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1
National Heart Centre Singapore
Singapore, Singapore, 169609