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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Empagliflozin in Patients with Heart Failure with Preserved Ejection Fraction in a Cardiology Outpatient Department
- ClinicalTrials.gov ID
- NCT06683053
- Acronym / sponsor ID
- ADDEMFEP / CMEP
- Conditions
- Congestive Heart Failure (CHF)
- Keywords
- congestive heart failure, preserved ejection fraction, empagliflozin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Conrado Roberto Hoffmann FilhoResearch network
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin 10 mg | Experimental | Drug: empagliflozinIn this group the patients will receive the medication empagliflozin 10 mg |
| Empagliflozin 25 mg | Experimental | Drug: empagliflozinIn this group the patients will receive the medication empagliflozin 25 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| empagliflozinComparing the benefits of both doses of empagliflozin (10 mg versus 25 mg) in terms of heart ejection fraction and quality of life. | Drug | Empagliflozin 10 mg, Empagliflozin 25 mg |
Primary outcome
Quality of life - application of Kansas City Cardiomyopathy Questionnaire
Time frame: At inclusion and 60 days after receiving the medication.
Applying the Kansas City Cardiomyopathy Questionnaire (KCCQ TSS) at inclusion and 60 days post-intervention in the two groups.
Quality of Life - Difference in the 6-minute walk test
Time frame: At inclusion and 60 days after receiving the medication.
Evaluate the difference in the 6-minute walk test before and after receiving the medication
Ejection fraction
Time frame: Before receiving the drug and 60 days after.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No. Due to current Brazilian data protection law all individual participant data must be kept in secrecy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conrado R Hoffmann Filho, Doctor principal investigator
Multidisciplinary Center for Specialized Education and Research Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing empagliflozin in people with Congestive Heart Failure (CHF), run by Conrado Roberto Hoffmann Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life - application of Kansas City Cardiomyopathy Questionnaire (time frame: At inclusion and 60 days after receiving the medication.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.