2025-525033-31-00招募中2 期
A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 67
- 主要终点
- Composite Z-score calculated as the average of Z-scores for the change from baseline at 24 weeks for the following 6 endpoints: NT-proBNP (log-transformed), Left ventricular end-diastolic volume index (LVEDVI), Left ventricular end-systolic volume index (LVESVI), E/e′ ratio, Global longitudinal strain (GLS), Left atrial volume index (LAVI).
研究概览
简要总结
To assess the effect of CRD-4730 on a composite score of cardiovascular endpoints in patients with HFrEF.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult male or female patient ≥ 18 years of age (or adult age as per country guidelines) and ≤ 85 years of age at the time of screening.
- •Has a medical history supporting a diagnosis of clinical chronic HF syndrome with a duration of at least 8 weeks prior to the time of screening and current NYHA functional class II to III (based on investigator’s assessment).
- •Has left ventricular ejection fraction (EF) ≤ 40% by a centrally read transthoracic echocardiogram (TTE) performed during screening.
- •Has N-terminal pro-B-type natriuretic peptide (NT-proBN) level ≥ 600 pg/mL (70.8 pmol/L) at the time of screening. Patients in atrial fibrillation or flutter at the time of screening are required to have an NT-proBNP level of ≥ 900 pg/mL (106.4 pmol/L).
- •Is receiving optimized and stable guideline directed HF therapy (per applicable regional or national guidelines).
- •Other protocol-defined criteria apply.
排除标准
- •Has evidence of recent HF exacerbation defined by hospitalization or requirement for intravenous (IV) or subcutaneous (SQ) diuretics within 4 weeks of the time of screening or during the Screening Period.
- •Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration.
- •Has acute coronary syndrome, unstable angina, persistent angina at rest, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, cardiac valve repair (surgical or nonsurgical) or surgical replacement, or carotid angioplasty within 8 weeks prior to screening or during the Screening Period.
- •Has clinical suspicion of infiltrative cardiomyopathy (eg, amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.
- •Other protocol-defined criteria apply.
研究组 & 干预措施
CRD-4730-matching placebo tablet
Placebo
干预措施: CRD-4730-matching placebo tablet (Drug)
CRD-4730, CRD-4730
Test
干预措施: CRD-4730 (Drug)
结局指标
主要结局
Composite Z-score calculated as the average of Z-scores for the change from baseline at 24 weeks for the following 6 endpoints: NT-proBNP (log-transformed), Left ventricular end-diastolic volume index (LVEDVI), Left ventricular end-systolic volume index (LVESVI), E/e′ ratio, Global longitudinal strain (GLS), Left atrial volume index (LAVI).
Composite Z-score calculated as the average of Z-scores for the change from baseline at 24 weeks for the following 6 endpoints: NT-proBNP (log-transformed), Left ventricular end-diastolic volume index (LVEDVI), Left ventricular end-systolic volume index (LVESVI), E/e′ ratio, Global longitudinal strain (GLS), Left atrial volume index (LAVI).
次要结局
- Changes in clinical laboratory results, vital signs, 12-lead Electrocardiogram (ECG) data.
- Change in echocardiography parameters from baseline at 12 and 24 weeks: − LVEDV, LVEDVI − LVESV, LVESVI − E/e′ ratio − GLS − LAVI
- Change in Kansas City cardiomyopathy questionnaire (KCCQ) Clinical summary score (CSS), Total symptom score (TSS), and Overall summary score (OSS) from baseline at 12 and 24 weeks.
- The number and percentage of participants with Treatment-emergent adverse event (TEAEs).
- Change in NT-proBNP from baseline at 12 and 24 weeks
研究者
Regulatory Affairs
Scientific
Cardurion Pharmaceuticals Inc.
研究点 (67)
Loading locations...
相似试验
招募中
3 期
A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular DiseaseAtherosclerotic Cardiovascular DiseaseNCT07551492Fujian Shengdi Pharmaceutical Co., Ltd.9,262
招募中
3 期
A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney DiseaseChronic Kidney DiseaseNCT07419828Shandong Suncadia Medicine Co., Ltd.5,386
尚未招募
2 期
A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney DiseaseChronic Kidney DiseaseNCT07555054Jiangsu Hansoh Pharmaceutical Co., Ltd.182
招募中
2 期
A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection FractionNCT07269717Shandong Suncadia Medicine Co., Ltd.48
进行中（未招募）
2 期
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute PancreatitisNCT07308392Fujian Shengdi Pharmaceutical Co., Ltd.119