Evaluation of the Use of Empagliflozin in Patients with Heart Failure with Preserved Ejection Fraction in a Cardiology Outpatient Department
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Quality of life - application of Kansas City Cardiomyopathy Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Empagliflozin 10 mg
In this group the patients will receive the medication empagliflozin 10 mg
干预措施: empagliflozin (Drug)
Empagliflozin 25 mg
In this group the patients will receive the medication empagliflozin 25 mg.
干预措施: empagliflozin (Drug)
结局指标
主要结局
Quality of life - application of Kansas City Cardiomyopathy Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
Conrado Roberto Hoffmann Filho
MD
Multidisciplinary Center for Specialized Education and Research Ltd.