NCT06915870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 27, 2025

Last Update Submit

April 4, 2025

Conditions

Diabetes MellitusHeart Failure

Keywords

ejection fractionangiotensin receptor neprilysin inhibitorDapagliflozinEmpagliflozin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

In group A, patients were prescribed Dapagliflozin 10 mg daily for 12 weeks

EXPERIMENTAL

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

In group B, patients were prescribed Empagliflozin 10 mg daily for 12 weeks

EXPERIMENTAL

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

Interventions

Dapagliflozin 10 mg dailyDRUG

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 A, patients were prescribed Dapagliflozin 10 mg daily for 12 weeks
Empagliflozin 10 MG ODDRUG

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

In group B, patients were prescribed Empagliflozin 10 mg daily for 12 weeks

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Hospital

Lahore, Punjab Province, 54600, Pakistan

Location

MeSH Terms

Conditions

Diabetes MellitusHeart Failure

Interventions

dapagliflozinempagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Department of Cardiology

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 8, 2025

Study Start

July 12, 2024

Primary Completion

January 13, 2025

Study Completion

January 13, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)