NCT05312021撤回2 期
Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction: a Safety and Efficacy Phase 2 Randomized Clinical Study (SP9In-HFpEF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in NT-proBNP
研究概览
简要总结
This study is to evaluate whether 16 weeks of treatment with IMR-687 is a safe and effective treatment for patients with Heart Failure with Preserved Ejection Fraction (HFpEF). The primary objective is to evaluate whether IMR-687 reduces NT-proBNP compared to placebo in these patients.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥45 years
- •Weight 60 to 160 kg, inclusive
- •LVEF ≥45% by echo within 6 months prior to Screening Visit
- •Symptoms of HFpEF requiring treatment with a diuretic(s) for at least 30 days prior to Screening
- •NYHA class II to IV at the time of Screening
- •LV hypertrophy, by echo within 6 months of screening, defined by either LV mass/BSA >95 g/m² for females and 115 g/m² for males or LV mass/m² for males >44 g/m2.7 for females and 48 g/m2.7 for males
- •NT-proBNP criteria either ≥300 pg/mL if in sinus rhythm or ≥700 pg/mL if in atrial fibrillation at screening
- •Elevated LV filling pressure criteria are defined as ONE OR MORE of the following:
- •HF hospitalization within 12 months prior to screening
- •LA enlargement (LA width (diameter) ≥3.8 cm, LA length ≥5.0 cm, LA area ≥20 cm² , LA volume ≥55 mL, or LA volume index >29 mL/m²) within 6 months of screening for a participant in sinus rhythm
- •Cardiac catheterization with at least one of the following in the 12 months prior to screening: rest LVEDP or PCWP ≥15 mm Hg, exercise PCWP ≥25 mm Hg, or fluid challenge PCWP ≥18 mm Hg
- •Echocardiogram criteria of one or more within 6 months of screening for a participant in sinus rhythm: E/e' (mean of lateral and septal) >13, E/e' lateral >12, or E/e' septal >14; or for a participant in atrial fibrillation: E/e' septal >11
- •For WOCBP: Two negative pregnancy tests and the use of highly effective contraception up to 3 months following end of study
排除标准
- •Any prior echocardiographic imaging measurement of LVEF <40%
- •Six-minute walk test (6MWT) distance <100 m or >450 m at Screening Visit
- •Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of >80
- •Major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to Screening Visit, or an elective PCI within 30 days prior to Screening Visit
- •Any clinical event within 6 months prior to Screening Visit that could have reduced the LVEF (eg, myocardial infarction, coronary artery bypass graft) unless an echocardiographic measurement was performed at least 1 month after the event confirming the LVEF to be ≥45%
研究组 & 干预措施
Placebo
Placebo Comparator
Participants randomly assigned to this arm will take placebo orally with food BID for 16 weeks.
干预措施: IMR-687 Placebo (Other)
IMR-687
Experimental
Participants randomly assigned to this arm will take IMR-687 orally with food BID for 16 weeks. IMR-687 dosing will be 300 mg BID for participants weighing less than 100 kg and 400 mg BID for participants weighing 100 kg or more.
干预措施: IMR-687 (Drug)
结局指标
主要结局
Change in NT-proBNP
时间窗: Baseline to Week 16
Calculated as the percent change from Baseline to Week 16 in NT-proBNP
次要结局
- Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index(Baseline to Week 16)
- Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio(Baseline to Week 16)
- Change in Echocardiography Parameters: Isovolumic Relaxation Time(Baseline to Week 16)
- Change From Baseline in Echocardiography Parameters: Left Ventricular Mass(Baseline to Week 16)
- Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus(Baseline to Week 16)
- Change in Baseline to Week 16 in the Kansas City Cardiomyopathy Questionnaire overall summary score(Baseline to Week 16)
- NYHA Classification(Baseline to Week 16)
- Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Relative Wall Thickness, Left Atrial Dimension(Baseline to Week 16)
- Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume(Baseline to Week 16)
- Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction(Baseline to Week 16)
- Change in Baseline to Week 16 in Clinical Composite Score(Baseline to Week 16)
- Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index(Baseline to Week 16)
- Change from Baseline to Week 16 for Estimated Glomerular Filtration Rate (eGFR)(Baseline to Week 16)
- To evaluate the safety and tolerability in IMR-687 versus placebo (TEAEs: Treatment-emergent adverse events(Baseline to Week 16)
- Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity(Baseline to Week 16)
- Exercise Capacity(Baseline to Week 16)
- Body Composition and Biomarker Measures(Baseline to Week 16)
- Change from Baseline to Week 16 for Interferon-gamma (Ifn-gamma)(Baseline to Week 16)
- Change from Baseline to Week 16 in body composition quantification by dual-energy X-ray absorptiometry scan (at selected sites)(Baseline to Week 16)
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