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

NCT06683053 | Active Not Recruiting Phase 3

• 1 other identifier: CMEP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congestive Heart Failure (CHF)

Keywords

congestive heart failure; preserved ejection fraction; empagliflozin

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Empagliflozin 10 mg

EXPERIMENTAL

In this group the patients will receive the medication empagliflozin 10 mg

Drug: empagliflozin

Empagliflozin 25 mg

EXPERIMENTAL

In this group the patients will receive the medication empagliflozin 25 mg.

Drug: empagliflozin

Interventions

empagliflozin DRUG

Comparing the benefits of both doses of empagliflozin (10 mg versus 25 mg) in terms of heart ejection fraction and quality of life.

Empagliflozin 10 mg; Empagliflozin 25 mg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Conrado Roberto Hoffmann Filho: lead

Study Sites (1)

Multidisciplinary Center for Specialized Education and Research Ltd.

Joinville, Santa Catarina, 89204250, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Conrado R Hoffmann Filho, Doctor

  Multidisciplinary Center for Specialized Education and Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Prospective, double-blind, randomized study comparing the efficacy and safety of empagliflozin at doses of 10 and 25 mg in patients with HFpEF. The Kansas City Cardiomyopathy Questionnaire (KCCQ TSS) will be applied at inclusion and 8 weeks post-intervention in the two groups. And the use of echocardiogram performed upon entering the study, with assessment of ventricular and atrial strain modalities, and being repeated at the end of the treatment period to try to detect possible differences between pre and post treatment with the proposed ISGLT2.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 12, 2024
• Study Start: March 17, 2023
• Primary Completion: April 29, 2024
• Study Completion: February 28, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)