Status:
UNKNOWN
Value of SGLT2 Inhibitor (Dapagliflozin) as an Added Therapy in Diabetic Patients With Heart Failure With Reduced Ejection Fraction; Randomized Controlled Clinical Trial
Lead Sponsor:
Damanhour University
Collaborating Sponsors:
Menoufia University
Conditions:
Heart Failure With Reduced Ejection Fraction (HFrEF)
Diabete Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Type 2 diabetes mellitus (T2DM) is a well-recognized independent risk factor for heart failure (HF). Whereas the prevalence of HF in the general population is 1-4%, it reaches approximately 12% in T2D...
Detailed Description
Primary Objective: The purpose of this study was to investigate the effect of Dapagliflozin, an inhibitor of sodium-glucose cotransporter 2, on cardiovascular Cardiomyopathy, morbidity and mortality i...
Eligibility Criteria
Inclusion
- Subjects with type-2 diabetes history \>=5 years
- HbA1C 6-10% with glucose control medications including insulin, metformin or sulfonylurea
- Medically stable
- Willing to participate and sign informed consent.
Exclusion
- GFR \<60 mL/min/1.73 m2
- Unstable or rapidly progressive renal disease
- Hypotension with SBP \<100 mmHg
- Hypersensitivity to dapagliflozin or any excipients
- Patients with severe hepatic impairment (Child-Pugh class C)
- Patients with active hepatitis B or C infection
- Any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrollment, as assessed by the investigator:
- Myocardial infarction
- Cardiac surgery or revascularization (CABG/PTCA)
- Unstable angina
- HF New York Heart Association (NYHA) Class IV
- Transient ischemic attack (TIA) or significant cerebrovascular disease
- Unstable or previously undiagnosed arrhythmia
- Established PAD
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04304560
Start Date
March 1 2020
End Date
April 1 2021
Last Update
March 11 2020
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