NCT05592275终止2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3540378 in Adults With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 332
- 试验地点
- 137
- 主要终点
- Change From Baseline in Left Atrial Reservoir Strain (LARS) at Week 26
研究概览
简要总结
The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction
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
- •Experienced an index event, defined as a recent hospitalization for HF requiring ≥1 bolus doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring ≥1 bolus doses of intravenous diuretics.
- •Documented LVEF of ≥50% within 12 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT).
- •Evidence of documentation of LVEF of ≥50% may also include participant medical records, discharge notes or a referral letter from the participant's physician or referring physician that details the participant's medical history.
- •Had evidence of clinical HF syndrome consisting of hospitalization for worsening heart failure (WHF) with intravascular volume overload (the index event), as determined by the investigator, based on appropriate supportive documentation at randomization, and defined by ≥2 of the following:
- •jugular venous distention
- •pitting edema in lower extremities (>1+)
- •pulmonary congestion on chest X-ray
- •pulmonary rales AND participant received treatment with IV diuretics.
- •Treatment for an urgent visit outside of of being hospitalized with WHF and intravascular volume overload (the index visit) requiring treatment with IV diuretics (defined as ≥2 IV doses) such as in the outpatient setting/emergency room/observation unit/infusion clinic with a clinical response within the past 2 weeks prior to randomization. Urgent visit is defined as an unplanned visit for HF defined by ≥2 of the following:
- •jugular venous distention
- •pitting edema in lower extremities (>1+)
- •pulmonary rales on lung examination.
- •NT-proBNP (>300 [sinus rhythm] or 600 pg/mL [atrial fibrillation or atrial flutter] OR BNP (>100 [sinus rhythm] or 200 pg/mL [atrial fibrillation or atrial flutter]) at screening.
- •eGFR of >20 mL/min/1.73 m² at V1 (screening; determined by local laboratory), derived from serum creatinine values, age, and sex based on the CKD-EPI equation.
排除标准
- •Prior documentation of low ventricle ejection fraction (LVEF) ≤45% in the past 12 months.
- •Have had acute coronary syndrome or percutaneous coronary intervention, coronary artery bypass graft, cardiac mechanical support implantation, within 3 months prior to V
- •(randomization), - or any other cardiac surgery planned during the study.
- •Have had left ventricular assist device (LVAD) or cardiac transplantation or have cardiac transplantation planned during the study.
- •Have hypertrophic cardiomyopathy (obstructive or nonobstructive), restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, known amyloid cardiomyopathy, or inherited cardiomyopathy.
- •Have a chronic pulmonary/lung disease (COPD), (pulmonary arterial hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.
- •Uncorrected thyroid disease.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received placebo administered once weekly as SC injection for 26 weeks.
干预措施: Placebo (Drug)
25 mg LY3540378
Experimental
Participants received 25 mg LY3540378 administered once weekly as subcutaneous (SC) injection for 26 weeks.
干预措施: LY3540378 (Drug)
50 mg LY3540378
Experimental
Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
干预措施: LY3540378 (Drug)
100 mg LY3540378
Experimental
Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
干预措施: LY3540378 (Drug)
结局指标
主要结局
Change From Baseline in Left Atrial Reservoir Strain (LARS) at Week 26
时间窗: Baseline, Week 26
Results are estimated using least squares (LS) mean from the mixed model repeated measures (MMRM) model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment\*Time + Baseline\*Treatment.
次要结局
- Change From Baseline in Left Atrial Reservoir Strain (LARS) at Week 12(Baseline, Week 12)
- Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at Week 12(Baseline, Week 12)
- Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at Week 26(Baseline, Week 26)
- Change From Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI) at Week 12(Baseline, Week 12)
- Change From Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI) at Week 26(Baseline, Week 26)
- Change From Baseline Left Atrial End-Systolic Volume Index (LAESVI) at Week 12(Baseline, Week 12)
- Change From Baseline Left Atrial End-Systolic Volume Index (LAESVI) at Week 26(Baseline, Week 26)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12(Baseline, Week 12)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26(Baseline, Week 26)
- Change From Baseline in Log-transformed Serum Creatinine at Week 12(Baseline, Week 12)
- Change From Baseline in Log-transformed Serum Creatinine at Week 26(Baseline, Week 26)
- Change From Baseline in Log-transformed Cystatin-C at Week 12(Baseline, Week 12)
- Change From Baseline in Log-transformed Cystatin-C at Week 26(Baseline, Week 26)
研究者
研究点 (137)
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