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

NCT ID: NCT06915870

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2025-01-13

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.

Conditions

Diabetes Mellitus; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Dapagliflozin 10 mg daily

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Empagliflozin 10 MG OD

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatima Maqsood

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fatima Maqsood

Head of the Department of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shaikh Zayed Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

271

Identifier Type: -

Identifier Source: org_study_id