Heart FailureNCT07112274
Empagliflozin on Patients With Preserved Heart Failure
A study testing Empagliflozin 10 MG in people with Heart Failure, run by Damanhour University at 1 site in Egypt.
Trial summary
The proposed research in this application will investigate the effect of empagliflozin on cardiac remodeling in patients with heart failure with preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 30 Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with declined baseline creatinine clearance below 60 ml/min
- Patients diagnosed with acute liver failure, AKI, hypoglycemia.
- Allergy to the ingredients which will be used in this study
- Patients with Diabetic ketoacidosis or non ketotic hyperosmolar hyperglycemia
- Severe hepatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Empagliflozin on Cardiac Remodeling in Non Diabetic Patients With Preserved Heart Failure
The proposed research in this application will investigate the effect of empagliflozin on cardiac remodeling in patients with heart failure with preserved ejection fraction.
Read the detailed description
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- About 50 cardiac non diabetic patients diagnosed with heart failure with preserved ejection fraction will be recruited from Mahalla Cardiac Centre outpatient clinics and randomize them into two groups, group on empagliflozin 10 mg once daily and the second group placebo.
- Blood samples will be collected before, and 3 months after intiation of the trial for evaluating Complete blood count (CBC), Serum creatinine (SCr), Aspartate aminotransferase (AST), Alanine transaminase(ALT), Hemoglobin A1C and two biomarkers which are: Human N-Terminal Pro Brain Natriuretic Peptide (NT-ProBNP) and soluble suppressor of tumorigenicity 2 (sST2) values in both groups.
- Echocardiogram will be assessed for the patients before and 3 months after the initiation of study and the values of :
- Left ventricular end systolic volume index (LVESI)
- Left atrial volume index (LAVI)
- Left ventricular mass index (LVMI)
- Ejection fraction (EF)
- Left atrium size
- Grade of diastolic dysfunction
- Cardiac output (C.O.P)
- Stroke volume (SV) Method:
- All participants will be randomly divided into two groups: group (A) for empagliflozin (n=25), group (B) for placebo (n=25) Sample sizes of 50 cardiac patients (25 empagliflozin group and 25 placebo group), achieves 90% power to detect a difference (7.5 ml/m2) in the mean change of Left ventricular end systolic volume index (LVESI) between the 2 groups, using independent t test, at a 0.05 significance level. The sample size was calculated using NCSS 2004 and PASS 2000 software
- Treatment group will receive empagliflozin 10 mg tablet once daily and control group will receive placebo tablet.
- Cardiac biomarkers will be assessed at baseline before trial initiation and 3 months after the initiation of trial
- SPSS will be used for statistical analysis of the data obtained in the research, measurement data using t test
- A value of P<0.05 was considered to indicate a statistically significant difference.
- Conditions
- Heart Failure
- Being tested
- Empagliflozin 10 MG, Placebo Tablet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Mellitofix
Treatment group will receive empagliflozin 10 mg tablet once daily
Placebo TabletOther
Also called Placebo
control group will receive placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin Group | Experimental | group (A) for empagliflozin (n=25), Receives: Drug: Empagliflozin 10 MG |
| Placebo Group | Placebo comparator | group (B) for placebo (n=25) Receives: Other: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-ProBNP
Human N-Terminal Pro Brain Natriuretic Peptide (NT-ProBNP)
Measured: 3 months
sST2
soluble suppressor of tumorigenicity 2 (sST2)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Oct 2022
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Model description
- All participants will be randomly divided into two groups: group (A) for empagliflozin (n=25), group (B) for placebo (n=25)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Study chair, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112274
- Sponsor's protocol ID
- EMPAGLIFLOZIN on HF
- Status last verified
- Nov 2025
- First submitted
- 1 Aug 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malik A, Brito D, Vaqar S, et al. Congestive Heart Failure. [Updated 2022 May 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430873/
Lee MMY, Brooksbank KJM, Wetherall K, Mangion K, Roditi G, Campbell RT, Berry C, Chong V, Coyle L, Docherty KF, Dreisbach JG, Labinjoh C, Lang NN, Lennie V, McConnachie A, Murphy CL, Petrie CJ, Petrie JR, Speirits IA, Sourbron S, Welsh P, Woodward R, Radjenovic A, Mark PB, McMurray JJV, Jhund PS, Petrie MC, Sattar N. Effect of Empagliflozin on Left Ventricular Volumes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure With Reduced Ejection Fraction (SUGAR-DM-HF). Circulation. 2021 Feb 9;143(6):516-525. doi: 10.1161/CIRCULATIONAHA.120.052186. Epub 2020 Nov 13.
PubMed 33186500
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empagliflozin on Cardiac Remodeling in Non Diabetic Patients With Preserved Heart Failure
- ClinicalTrials.gov ID
- NCT07112274
- Acronym / sponsor ID
- EMPAGLIFLOZIN on HF
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 8 Aug 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.
The proposed research in this application will investigate the effect of empagliflozin on cardiac remodeling in patients with heart failure with preserved ejection fraction.
Detailed description
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- About 50 cardiac non diabetic patients diagnosed with heart failure with preserved ejection fraction will be recruited from Mahalla Cardiac Centre outpatient clinics and randomize them into two groups, group on empagliflozin 10 mg once daily and the second group placebo.
- Blood samples will be collected before, and 3 months after intiation of the trial for evaluating Complete blood count (CBC), Serum creatinine (SCr), Aspartate aminotransferase (AST), Alanine transaminase(ALT), Hemoglobin A1C and two biomarkers which are: Human N-Terminal Pro Brain Natriuretic Peptide (NT-ProBNP) and soluble suppressor of tumorigenicity 2 (sST2) values in both groups.
- Echocardiogram will be assessed for the patients before and 3 months after the initiation of study and the values of :
- Left ventricular end systolic volume index (LVESI)
- Left atrial volume index (LAVI)
- Left ventricular mass index (LVMI)
- Ejection fraction (EF)
- Left atrium size
- Grade of diastolic dysfunction
- Cardiac output (C.O.P)
- Stroke volume (SV) Method:
- All participants will be randomly divided into two groups: group (A) for empagliflozin (n=25), group (B) for placebo (n=25) Sample sizes of 50 cardiac patients (25 empagliflozin group and 25 placebo group), achieves 90% power to detect a difference (7.5 ml/m2) in the mean change of Left ventricular end systolic volume index (LVESI) between the 2 groups, using independent t test, at a 0.05 significance level. The sample size was calculated using NCSS 2004 and PASS 2000 software
- Treatment group will receive empagliflozin 10 mg tablet once daily and control group will receive placebo tablet.
- Cardiac biomarkers will be assessed at baseline before trial initiation and 3 months after the initiation of trial
- SPSS will be used for statistical analysis of the data obtained in the research, measurement data using t test
- A value of P<0.05 was considered to indicate a statistically significant difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All participants will be randomly divided into two groups: group (A) for empagliflozin (n=25), group (B) for placebo (n=25)
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin Group | Experimental | Drug: Empagliflozin 10 MGgroup (A) for empagliflozin (n=25), |
| Placebo Group | Placebo comparator | Other: Placebo Tabletgroup (B) for placebo (n=25) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients with declined baseline creatinine clearance below 60 ml/min
- Patients diagnosed with acute liver failure, AKI, hypoglycemia.
- Allergy to the ingredients which will be used in this study
- Patients with Diabetic ketoacidosis or non ketotic hyperosmolar hyperglycemia
- Severe hepatic disease.
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 |
|---|---|---|
| Empagliflozin 10 MGAlso: MellitofixTreatment group will receive empagliflozin 10 mg tablet once daily | Drug | Empagliflozin Group |
| Placebo TabletAlso: Placebocontrol group will receive placebo tablet. | Other | Placebo Group |
Primary outcome
NT-ProBNP
Time frame: 3 months
Human N-Terminal Pro Brain Natriuretic Peptide (NT-ProBNP)
sST2
Time frame: 3 months
soluble suppressor of tumorigenicity 2 (sST2)
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 3 Dec 2025.
- BackgroundMalik A, Brito D, Vaqar S, et al. Congestive Heart Failure. [Updated 2022 May 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430873/
- Background: PubMed 33186500Lee MMY, Brooksbank KJM, Wetherall K, Mangion K, Roditi G, Campbell RT, Berry C, Chong V, Coyle L, Docherty KF, Dreisbach JG, Labinjoh C, Lang NN, Lennie V, McConnachie A, Murphy CL, Petrie CJ, Petrie JR, Speirits IA, Sourbron S, Welsh P, Woodward R, Radjenovic A, Mark PB, McMurray JJV, Jhund PS, Petrie MC, Sattar N. Effect of Empagliflozin on Left Ventricular Volumes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure With Reduced Ejection Fraction (SUGAR-DM-HF). Circulation. 2021 Feb 9;143(6):516-525. doi: 10.1161/CIRCULATIONAHA.120.052186. Epub 2020 Nov 13.
- 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.
Rehab H Werida, Ass Prof. study chair
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin 10 MG in people with Heart Failure, run by Damanhour University at 1 site in Egypt.
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 0 inclusion and 5 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 3 Dec 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
NT-ProBNP (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07112274, which also lists 2 linked publications.
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 3 Dec 2025.