Corticotrophin Releasing Factor 2 for the Treatment of Worsening Heart Failure (WHF) - The CRAFT-WHF Study
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 300
- 试验地点
- 62
- 主要终点
- Left Atrial Volume index (LAVi)
研究概览
简要总结
This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)
详细描述
This is a phase 2, randomized, double-blind, placebo-controlled study designed to assess the dose-dependent effects of 3 doses of the corticotropin-releasing factor type 2 (CRF2) peptide agonist, COR-1167, in subjects with WHF, defined as subjects requiring urgent administration of intravenous (i.v.) diuretics due to worsening of signs and symptoms of heart failure (HF) associated with volume overload
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor CRO
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Heart failure hospitalization (HFH) during previous 12 months
- •Prescribed an oral loop diuretic for at least 1 month preceding the index event
- •NT-proBNP ≥1,000 pg/mL or BNP ≥250 pg/mL
- •Requires treatment with i.v. diuretics for volume overload
- •At least 1 risk factor for diuretic resistance
- •Admitted to the hospital not more than 48 hours prior to randomization
排除标准
- •Index event primarily triggered by an acute event (e.g. AMI, PE, arrhythmia)
- •Requirement for i.v. inotropic therapy or i.v. vasodilators, mechanical ventilation, high-flow oxygen therapy, or NIV
- •Requirement for, or planned use of LVADs, IABP, or any type of MCS
- •History of solid organ transplant or active on a transplant list
- •SBP <100 mmHg
- •eGFR < 20 mL/min/1.73 m2
- •CABG, PCI, implantation of CRT, heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study
- •Severe stenotic cardiac valvular disease
- •Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (> 2 L/min)
- •Uncorrected severe hyperthyroidism or hypothyroidism
- •Severe restrictive, obstructive, or infiltrative cardiomyopathy
- •Body weight < 70 kg
- •Use of any investigational drug(s) within 5 half-lives of screening
- •At high risk of death (defined as life expectancy ≤1 year) from causes other than heart failure or any disease that, in the opinion of the Investigator, will preclude their safe participation in this study, and will make implementation of the protocol or interpretation of the study results difficult
- •Presence of any other conditions (e.g. geographic, social) actual or anticipated, that the Investigator feels would restrict or limit the subject's participation or compliance with all study procedures Subject is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
研究组 & 干预措施
COR-1167 high dose
干预措施: COR-1167 (Drug)
Placebo
干预措施: Placebo (Drug)
COR-1167 low dose
干预措施: COR-1167 (Drug)
COR-1167 intermediate dose
干预措施: COR-1167 (Drug)
结局指标
主要结局
Left Atrial Volume index (LAVi)
时间窗: 2 days
Changes in LAVi - LAV-i is an index of cardiac function measured by echocardiogram
Body weight
时间窗: 7 days
Changes in body weight
NT-proBNP
时间窗: 7 days
Changes in NT-proBNP
Body weight
时间窗: 7 days
Changes in body weight
NT-proBNP
时间窗: 7 days
Changes in NT-proBNP
Left Atrial Volume index (LAVi)
时间窗: 2 days
Changes in LAVi - LAV-i is an index of cardiac function measured by echocardiogram
Natriuresis
时间窗: 24 hours
Urinary sodium excretion
Kansas City Cardiomyopathy Questionnaire (KCCQ)-Total Symptom Score (TSS)
时间窗: 28 days
Changes in KCCQ-TSS - The score ranges from 0 to 100 with higher score indicating a better health status
次要结局
未报告次要终点