Comparison of Empagliflozin and Dapagliflozin in Patients With Heart Failure Taking Standard Treatment

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diabetes Mellitus
• Intervention / Treatment: Drug: Dapagliflozin 10 mg daily; Drug: Empagliflozin 10 MG OD

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54600
      • Shaikh Zayed Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In group A, patients were prescribed Dapagliflozin 10 mg daily for 12 weeks; 108 patients fulfilling the selection criteria were enrolled from OPD. Informed consent and demographic data of all the patients were obtained. Then patients were randomly divided in two groups by using lottery method. In group A, patients were prescribed Dapagliflozin 10 mg daily for 12 weeks	Drug: Dapagliflozin 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
Experimental: In group B, patients were prescribed Empagliflozin 10 mg daily for 12 weeks; In group B, patients were prescribed 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	Drug: Empagliflozin 10 MG OD; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Empagliflozin and Dapagliflozin in heart failure in diabetic patients taking Sodium-glucose cotransporter-2 and angiotensin receptor neprilysin inhibitor	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	12 weeks

Collaborators and Investigators

• Sponsor: Fatima Maqsood

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Actual): January 13, 2025
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Dapagliflozin; Empagliflozin; ejection fraction; angiotensin receptor neprilysin inhibitor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin; Dapagliflozin
• Other Study ID Numbers: 271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No