Empagliflozin on Patients With Preserved Heart Failure

NCT ID: NCT07112274

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-07-30

Brief 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.

Detailed Description

1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.

2. All participants should agree to take part in this clinical study and will provide informed consent.

3. 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.

4. 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.

5. Echocardiogram will be assessed for the patients before and 3 months after the initiation of study and the values of :

1. Left ventricular end systolic volume index (LVESI)

2. Left atrial volume index (LAVI)

3. Left ventricular mass index (LVMI)

4. Ejection fraction (EF)

5. Left atrium size

6. Grade of diastolic dysfunction

7. Cardiac output (C.O.P)

8. 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

Study Design

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

Study Groups

Empagliflozin Group

group (A) for empagliflozin (n=25),

Group Type: EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type: DRUG

Treatment group will receive empagliflozin 10 mg tablet once daily

Placebo Group

group (B) for placebo (n=25)

Group Type: PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type: OTHER

control group will receive placebo tablet.

Interventions

Empagliflozin 10 MG

Treatment group will receive empagliflozin 10 mg tablet once daily

Intervention Type: DRUG

Placebo Tablet

control group will receive placebo tablet.

Intervention Type: OTHER

Other Intervention Names

Mellitofix; Placebo

Eligibility Criteria

Exclusion Criteria

1. Patients with declined baseline creatinine clearance below 60 ml/min

2. Patients diagnosed with acute liver failure, AKI, hypoglycemia.

3. Allergy to the ingredients which will be used in this study

4. Patients with Diabetic ketoacidosis or non ketotic hyperosmolar hyperglycemia

5. Severe hepatic disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rehab H Werida, Ass Prof.

Role: STUDY_CHAIR

Damanhour University

Locations

Rehab Hussein Werida

Damanhūr, Elbehairah, Egypt

Countries

Egypt

References

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/

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 33186500 (View on PubMed)

Other Identifiers

EMPAGLIFLOZIN on HF

Identifier Type: -

Identifier Source: org_study_id