Empagliflozin on Patients With Preserved Heart Failure

NCT07112274 | Completed

• 1 other identifier: EMPAGLIFLOZIN on HF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• NT-ProBNP

  Human N-Terminal Pro Brain Natriuretic Peptide (NT-ProBNP)

  3 months

• sST2

  soluble suppressor of tumorigenicity 2 (sST2)

  3 months

Study Arms (2)

Empagliflozin Group

EXPERIMENTAL

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

Drug: Empagliflozin 10 MG

Placebo Group

PLACEBO COMPARATOR

group (B) for placebo (n=25)

Other: Placebo Tablet

Interventions

Empagliflozin 10 MG DRUG

Treatment group will receive empagliflozin 10 mg tablet once daily

Also known as: Mellitofix

Empagliflozin Group

Placebo Tablet OTHER

control group will receive placebo tablet.

Also known as: Placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Rehab Hussein Werida

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (2)

• 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/

  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.

  PMID: 33186500 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rehab H Werida, Ass Prof.

  Damanhour University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will be randomly divided into two groups: group (A) for empagliflozin (n=25), group (B) for placebo (n=25)

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: October 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)