A Proof of Biological Efficacy Study Assessing the Potential of Piboserod, a Specific 5-HT4 Antagonist, for the Treatment of Symptomatic Congestive Heart Failure on Top of Usual Evidence Based Pharmacological Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 17
- 主要终点
- Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging
研究概览
简要总结
The purpose of this study is to determine whether piboserod, a serotonin-4 receptor antagonist, is effective for the treatment of patients with congestive heart failure.
详细描述
Despite intensive research for decades, mortality and morbidity in chronic heart failure remains quite high. There is an obvious need for new drugs, especially drugs which may have a different mode of action than the existing ones on the market.
The purpose of this trial is to evaluate whether a new drug candidate, piboserod, has beneficial biological effects in stable outpatients with symptomatic heart failure receiving evidence based treatment for heart failure and to assess safety and tolerability of this treatment.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of CHF (NYHA class II-IV)
- •Locally determined LVEF < 0.35 (by CMR, echocardiography, LV angiography, or radionuclide cardioangiography)
- •Stable sinus rhythm
- •Stable evidence based pharmacological treatment for CHF.
排除标准
- •Unstable patients hospitalised within last 2 weeks
- •Baseline prolongation of QTc interval
- •Atrial fibrillation at randomisation
- •MI or re-vascularisation last 3 months
- •Stroke last 3 months.
结局指标
主要结局
Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging
时间窗: 6 months
次要结局
- Change in LV systolic and diastolic volume (and/or diameter) by CMR(6 months)
- Change in NYHA functional class(6 months)
- Change in various biomarkers for heart failure(6 months)
- Change in QoL-scores(6 months)
- Change in 6-minute walk distance(6 months)