A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN ORAL BRANCHED-CHAIN KETOACID DEHYDROGENASE KINASE INHIBITOR, PF-07328948, IN ADULTS WITH HEART FAILURE (BRANCH-HF) (BRANCH-HF)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 620
- 主要终点
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Aged 18 years or older.
- •Clinically confirmed to have a diagnosis of heart failure for at least 3 months
- •New York Heart Association Class II-IV symptoms
- •Left ventricular ejection fraction greater than 40%
- •Body mass index of 27 kg/m2 or higher
- •Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score < 85
- •Walking distance of 75 meters or more in six-minute walking test
排除标准
- •Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.
- •Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor.
- •History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes
- •Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor
结局指标
主要结局
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS)
时间窗: Baseline, week 36
-KCCQ is a 23-item heart-failure specific questionnaire quantified into the following scores: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy, total symptom score, overall summary score, and clinical summary score. To facilitate interpretation, all scores are presented on a scale of 0 to 100 points, with lower scores indicating more severe symptoms and/or limitations, and a score of 100 indicating no symptoms, no limitations, and excellent quality of life.
Number of Participants with Clinical Events
时间窗: over 36 weeks
-Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.
Change From Baseline in 6-Minute Walk Test (6MWD)
时间窗: Baseline, week 36 post-dose
-A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(Baseline, up to week 40)
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-23 TSS), Clinical Summary Score (CSS) and physical limitation(Baseline, week 36)
- Change From Baseline in 6-minute walk test distance (6MWD)(Baseline, week 36)
- Change From Baseline in Peak Oxygen Consumption (pVO2)(Baseline, Week 36)
- Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration(Baseline, Week 36)