Value of SGLT2 Inhibitor (Dapagliflozin) as an Added Therapy in Diabetic Patients With Heart Failure With Reduced Ejection Fraction; Randomized Controlled Clinical Trial

Sponsor
Damanhour University
Study ID
NCT04304560
Phase
PHASE2
Status
Unknown

Conditions

  • Cardiomyopathies
  • Diabete Type 2
  • Heart Failure With Reduced Ejection Fraction (HFrEF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG — DRUG
    inhibitor of sodium-glucose cotransporter 2
  • Placebo oral tablet — DRUG
    Similar Placebo oral tablet

Study Details

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 T2DM patients. In 1972, Rubler reported a specific diabetes-associated cardiac injury called diabetic cardiomyopathy. This cardiomyopathy is defined by ventricular dysfunction occurring without coronary disease or hypertension. Diabetic cardiomyopathy is also characterized by left ventricular (LV) hypertrophy, diastolic dysfunction and myocardial fibrosis. A large body of work indicates that diabetic cardiomyopathy is associated with altered cardiac energy metabolism. Indeed, in obese T2DM patients, heart lipid uptake is increased. Several studies support that free fatty acid (FFA) accumulation leads to the increased production of diacylglycerol (DAG), ceramides and reactive oxygen species (ROS), affecting cardiac insulin sensitivity and cardiac contractility. On the other hand, hyperglycemia and glucose overload have been involved in cardiac hypertrophy and dysfunction in the context of T2DM and obesity. The diabetic heart is simultaneously characterized by impaired insulin-stimulated glucose uptake and obvious signs of glucose overload, such as ROS and advanced glycation end-product (AGE) production as well as hexosamine pathway chronic activation. Interestingly, when comparing diabetic and nondiabetic obese patients, we previously demonstrated that hyperglycemia per se plays a central role in the impaired cardiac mitochondrial activity associated with myocardial contractile dysfunction.

Key Dates

Start date
Mar 31, 2020
Status verified
Mar 2020
Primary completion
Mar 31, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control Group
    Control group will receive the standard therapy for DM \& HFrEF and placebo.
  • Experimental: Dapagliflozin
    Intervention group will receive 10mg of Dapagliflozin (Forxiga) ® tablet and standard therapy for HFrEF.

Primary Outcome Measure

LV dimensions [ Time Frame: 3 Months ]

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