NCT00662116终止2 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure
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
- 160
- 主要终点
- The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test
研究概览
简要总结
This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of diabetes or hypertension requiring therapy
- •EF >/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of E/E'>/= 12 determined by echo within 1 year
- •previous hospitalization for heart failure or previous BNP >100 pg/mL.
排除标准
- •Clinically significant valvular disease
- •history of stroke/TIA or reversible ischemic neurological defect w/i 6 mths
- •history of acute MI within 6 months
- •severe COPD
- •active or treated malignancies (except basal cell carcinoma)
- •significant systemic illnesses that would prohibit completion of the study or compliance
研究组 & 干预措施
1
Experimental
干预措施: alagebrium (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test
时间窗: Assessed at baseline, week 12 and week 24
次要结局
- QOL as assessed by the Kansas City Cardiomyopathy Questionnaire(baseline, week 12 and week 24)
- To assess New York Heart Association Classification(Baseline, week 12 and week 24)
- To evaluate cardiovascular death or hospitalization for heart failure(Will be assessed during the entire 24 wk trial)
研究者
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