NCT01235273暂停2 期
Phase 2 Study of Growth Hormone Administration in Patients With Chronic Heart Failure and Low IGF-1 Levels
Federico II University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.
研究概览
简要总结
The objective of the study is to determine whether treatment of the low IGF-1 syndrome in patients with CHF is able to modify some functional parameters, recognized as valid surrogate end-points of CHF progression.
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)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of either sex affected by CHF NYHA class II-III, secondary to ischemic or idiopathic dilated cardiomyopathy
- •age range 30-80 years
- •stable medications for at least two months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated).
- •LV ejection fraction 40% or less
- •Peak VO2 consumption during a CPET ≤ 16 ml/kg/min.
- •LV end-diastolic dimension 55 mm or more
- •low IGF-1 levels and a satisfactory response to an IGF-1 generation test
- •informed consent
排除标准
- •haemodynamic clinically significant primary valvular disease or significant congenital heart disease
- •acute pericarditis/myocarditis
- •inability to perform a bicycle exercise test
- •Poorly controlled diabetes mellitus (HbA1c >8.5)
- •active proliferative or severe non-proliferative diabetic retinopathy
- •active and/or history of malignancy
- •evidence of progression or recurrence of an underlying intracranial tumor
- •unstable angina or recent myocardial infarction (less than 5 months)
- •severe liver disease
- •serum creatinine levels >2.5 mg/dl
- •Inability to cooperate or administer the study drug
- •Patients participating in any other clinical study, within 30 days prior to screening visit and/or during this particular study period
研究组 & 干预措施
GH replacement therapy
Experimental
干预措施: Growth Hormone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.
时间窗: 9 months
次要结局
未报告次要终点
研究者
Antonio Cittadini
Associate Professor of Internal Medicine
Federico II University
研究点 (1)
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