Evaluation of the Use of Empagliflozin in Patients with HF with PEF in a Cardiology Outpatient Department (ADDEMFEP)

Evaluation of the Use of Empagliflozin in Patients with Heart Failure with Preserved Ejection Fraction in a Cardiology Outpatient Department

This study aims to evaluate whether the use of a 25 mg dose of empagliflozin compared to the 10 mg dose used would bring additional benefits in the improvement outcomes of the Kansas City Cardiomyopathy Questionnaire (KCCQ SST), in the 6-minute walk test (6MWT) without causing significant side effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Congestive Heart Failure (CHF)
• Intervention / Treatment: Drug: empagliflozin

Detailed Description

This study aims to evaluate whether the use of a 25 mg dose of empagliflozin compared to the 10 mg dose used would bring additional benefits in the improvement outcomes of the Kansas City Cardiomyopathy Questionnaire (KCCQ SST), in the 6-minute walk test (6MWT) without causing significant side effects. Patients will be randomized and will receive one of the two doses of empagliflozin. All patients in both groups will be equally evaluated by the tests, before receiving the medication, and also 8 weeks after.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89204250
      • Multidisciplinary Center for Specialized Education and Research Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients >18 years old.
• Echocardiogram with ejection fraction > 50%
• Patients must present at least one of the following items to be included in the study: Patients with a previous diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) who have improved on the echocardiogram to an ejection fraction above 50%, patients with a previous ejection fraction between 40-49% who have progressed to ejection fraction above 50%. For these groups there is no need to perform the score for heart failure with preserved ejetion fraction score (since the diagnosis of HF was already known). Patients with signs/symptoms of HFpEF, who present structural morphological changes such as left atrium enlargement or left ventricular hypertrophy (LVH).
• After recently undergoing the score for heart failure with preserved ejetion fraction score (H2FPEF), patients who present scores that place them at least at an intermediate probability of HFpEF would be eligible for entry into the study.
• Signing the consent form

Exclusion Criteria:

• Patient with type I DM
• Estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology (CKD EPI) equation, with a cutoff of <20 mL/mm/1.73m2
• Patient currently using SGLT2 antagonists
• Patient with a history of allergic reaction or significant sensitivity to empagliflozin
• Female patient who is pregnant or considering becoming pregnant during the study or for 3 months after the last dose of study medication
• Patients that are breastfeeding
• Patients considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Patients with a previous diagnosis of HFpEF who presents a low probability of diagnosis after being re-stratified by the previously mentioned score
• Patients unable to walk or understand/comply with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empagliflozin 10 mg; In this group the patients will receive the medication empagliflozin 10 mg	Drug: empagliflozin; Comparing the benefits of both doses of empagliflozin (10 mg versus 25 mg) in terms of heart ejection fraction and quality of life.
Experimental: Empagliflozin 25 mg; In this group the patients will receive the medication empagliflozin 25 mg.	Drug: empagliflozin; Comparing the benefits of both doses of empagliflozin (10 mg versus 25 mg) in terms of heart ejection fraction and quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life - application of Kansas City Cardiomyopathy Questionnaire	Applying the Kansas City Cardiomyopathy Questionnaire (KCCQ TSS) at inclusion and 60 days post-intervention in the two groups.	At inclusion and 60 days after receiving the medication.
Quality of Life - Difference in the 6-minute walk test	Evaluate the difference in the 6-minute walk test before and after receiving the medication	At inclusion and 60 days after receiving the medication.
Ejection fraction	Using the echocardiogram upon entering the study, with assessment of ventricular and atrial strain modalities, repeating the same at the end of the treatment period to try to detect possible differences between pre and post treatment with the proposed Sodium-Glucose Transporter 2 Inhibitors (ISGLT2).	Before receiving the drug and 60 days after.

Collaborators and Investigators

• Sponsor: Conrado Roberto Hoffmann Filho
• Investigators: Principal Investigator: Conrado R Hoffmann Filho, Doctor, Multidisciplinary Center for Specialized Education and Research Ltd.

Publications and helpful links

Helpful Links

• Heart failure with preserved ejection fraction in patients with normal natriuretic peptide levels is associated with increased morbidity and mortality.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Actual): April 29, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Estimated): November 11, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 8, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: congestive heart failure; empagliflozin; preserved ejection fraction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin
• Other Study ID Numbers: CMEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to current Brazilian data protection law all individual participant data must be kept in secrecy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No