Diabetes MellitusNCT06915870
Comparison of Empagliflozin and Dapagliflozin in Patients With Heart Failure Taking Standard Treatment
A study testing Dapagliflozin 10 mg daily and Empagliflozin 10 MG OD in people with Diabetes Mellitus and Heart Failure, run by Fatima Maqsood at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Heart Failure
- What is being tested?
- Dapagliflozin 10 mg daily and Empagliflozin 10 MG OD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jul 2024to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Dapagliflozin 10 mg daily, Empagliflozin 10 MG OD
- Keywords
- ejection fraction, angiotensin receptor neprilysin inhibitor, Dapagliflozin, Empagliflozin
- Medical subject headings
- Diabetes Mellitus, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Empagliflozin 10 MG OD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start12 Jul 2024
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Maqsood
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Fatima Maqsood, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915870
- Sponsor's protocol ID
- 271
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Empagliflozin and Dapagliflozin in Patients With Heart Failure Taking Standard Treatment
- ClinicalTrials.gov ID
- NCT06915870
- Acronym / sponsor ID
- 271
- Conditions
- Diabetes Mellitus, Heart Failure
- Keywords
- ejection fraction, angiotensin receptor neprilysin inhibitor, Dapagliflozin, Empagliflozin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fatima MaqsoodOther government
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In group A, patients were prescribed Dapagliflozin 10 mg daily for 12 weeks | Experimental | Drug: Dapagliflozin 10 mg daily108 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 |
| In group B, patients were prescribed Empagliflozin 10 mg daily for 12 weeks | Experimental | Drug: Empagliflozin 10 MG ODIn 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 mg dailyDapagliflozin 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 | In group A, patients were prescribed Dapagliflozin 10 mg daily for 12 weeks |
| Empagliflozin 10 MG ODEmpagliflozin 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 | In group B, patients were prescribed Empagliflozin 10 mg daily for 12 weeks |
Primary outcome
Comparison of Empagliflozin and Dapagliflozin in heart failure in diabetic patients taking Sodium-glucose cotransporter-2 and angiotensin receptor neprilysin inhibitor
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin 10 mg daily and Empagliflozin 10 MG OD in people with Diabetes Mellitus and Heart Failure, run by Fatima Maqsood at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Empagliflozin and Dapagliflozin in heart failure in diabetic patients taking Sodium-glucose cotransporter-2 and angiotensin receptor neprilysin inhibitor (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.