NCT06683053Active, not recruitingPhase 3
Evaluation of the Use of Empagliflozin in Patients with HF with PEF in a Cardiology Outpatient Department
Evaluation of the Use of Empagliflozin in Patients with Heart Failure with Preserved Ejection Fraction in a Cardiology Outpatient Department
Source: ClinicalTrials.gov · Last updated 12 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 5 Nov 2024
- Start date
- 17 Mar 2023
- Primary completion date
- 29 Apr 2024
- Lead sponsor
- Conrado Roberto Hoffmann Filho
- Diseases
- Heart failure
- NCT number
- NCT06683053
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 90
- From 17 Mar 2023 to the primary completion date, 29 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient currently using SGLT2 antagonists
- Female patient who is pregnant or considering becoming pregnant during the study or for 3 months after the last dose of study medication
- Patients with a previous diagnosis of HFpEF who presents a low probability of diagnosis after being re-stratified by the previously mentioned score
Other illness
- Patient with a history of allergic reaction or significant sensitivity to empagliflozin
Lab values
- Estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology (CKD EPI) equation, with a cutoff of \<20 mL/mm/1.73m2
Other
- Patient with type I DM
- Patients that are breastfeeding
- Patients considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Patients unable to walk or understand/comply with the study protocol.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multidisciplinary Center for Specialized Education and Research Ltd. Coordinator of this site? Confirm its status | Joinville | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.