Congestive Heart Failure (CHF)Phase 3ADDEMFEPNCT06683053
Evaluation of the Use of Empagliflozin in Patients with HF with PEF in a Cardiology Outpatient Department
A Phase 3 study testing empagliflozin in people with Congestive Heart Failure (CHF), run by Conrado Roberto Hoffmann Filho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure (CHF)
- What is being tested?
- empagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Mar 2023to 28 Feb 2025
- Phase
- Phase 3
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Multidisciplinary Center for Specialized Education and Research Ltd.
Joinville, Santa Catarina, 89204250
About this study
Official title: 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.
Read the 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.
- Conditions
- Congestive Heart Failure (CHF)
- Being tested
- empagliflozin
- Keywords
- congestive heart failure, preserved ejection fraction, empagliflozin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empagliflozinDrug
Comparing the benefits of both doses of empagliflozin (10 mg versus 25 mg) in terms of heart ejection fraction and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin 10 mg | Experimental | In this group the patients will receive the medication empagliflozin 10 mg Receives: Drug: empagliflozin |
| Empagliflozin 25 mg | Experimental | In this group the patients will receive the medication empagliflozin 25 mg. Receives: Drug: empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: Before receiving the drug and 60 days after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start17 Mar 2023
- Primary completion29 Apr 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure (CHF)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conrado Roberto Hoffmann Filho
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Conrado Roberto Hoffmann Filho, Multidisciplinary Center for Specialized Education and Research Ltd.
- Investigators
- Conrado R Hoffmann Filho, Doctor, Principal investigator, Multidisciplinary Center for Specialized Education and Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683053
- Sponsor's protocol ID
- CMEP
- Acronym
- ADDEMFEP
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to current Brazilian data protection law all individual participant data must be kept in secrecy.