Diabetes Mellitus, Heart Failure
Conditions
Keywords
ejection fraction, angiotensin receptor neprilysin inhibitor, Dapagliflozin, Empagliflozin
Brief summary
Participants were enrolled and randomly divided in two groups. In group A, participants were prescribed Dapagliflozin 10 mg daily. In group B, participants were prescribed Empagliflozin 10 mg daily. All participants were followed-up in OPD after 12 weeks for assessment of ejection fraction.
Detailed description
This study's rationale is to examine the effects of dapagliflozin and empagliflozin on heart failure in patients receiving ARNI and SGLT2. Research revealed that the two medications results are identical. Although the cardiac functioning improved better with empagliflozin. But limited data has been available in this regard, while no local trial conducted before. Thus, in routine SGLT2 and ARNI are given to control glycemic level and maintain cardiac functioning. However, addition of Empagliflozin and Dapagliflozin can be more beneficial in improving cardiac functioning and reducing adverse events. Therefore the investigators planned to conduct this study to get evidence in local population. This will help to improve practice.
Interventions
DRUGDapagliflozin 10 mg daily
Dapagliflozin 10 mg daily for 12 weeks. Standard SGLT2 and ARNI treatment was given as per standard protocol. All patients were followed-up in OPD after 12 weeks for assessment of ejection fraction by using echocardiography
Empagliflozin 10 mg daily for 12 weeks. Standard SGLT2 and ARNI treatment was given as per standard protocol. All patients were followed-up in OPD after 12 weeks for assessment of ejection fraction by using echocardiography
Sponsors
Fatima Maqsood
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 40-60 years of either gender diagnosed with heart failure ( Heart failure was defined as presence of ejection fraction \<50% on echocardiography, with pedal edema, water in lungs, paroxysmal nocturnal dyspnea or exertional limitation due to failure of ventricular fillings) * Diabetic patients, with HBA1c\>6.5% for \>1 year already taking SGLT-2 and ARNI inhibitor.
Exclusion criteria
* Patients already had valvular device, mitral or aortic valve regurgitation or stenosis detected on echocardiography, heart transplantation, chronic renal failure or dialysis patients, cardiomyopathy, liver failure or malignancy. * Patients already taking trial drugs or other anti-glycemic or cardiac medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Empagliflozin and Dapagliflozin in heart failure in diabetic patients taking Sodium-glucose cotransporter-2 and angiotensin receptor neprilysin inhibitor | 12 weeks | Participants fulfilling criteria were included. Baseline ejection fraction was calculated. Total 12 weeks of therapy was given. One group was administered dapagliflozin where as empagliflozin was administered to other group. Any variation in condition was assessed by ejection fraction findings of both groups after 12 weeks |
Countries
Pakistan
Outcome results
None listed