NCT01576861已完成2 期
Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
Federico II University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2007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
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Peak Oxygen Consumption
研究概览
简要总结
After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.
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
- Single (Investigator)
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
- •Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
- •Age range 18-80 years
- •Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study
- •Left Ventricular ejection fraction 40% or less
- •Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/ml)
- •Written Informed consent
排除标准
- •Acute proliferative or severe non-proliferative diabetic retinopathy
- •Active malignancy
- •Evidence of progression or recurrence of an underlying intracranial tumor
- •Unstable Angina or recent myocardial infarction
- •Serum Creatinine levels > 2.5 mg/dl
- •Severe liver disease (Child-Pugh B-C)
研究组 & 干预措施
GH replacement
Experimental
Patients will receive 48 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,012 mg/kg every second day, added to their background optimized CHF therapy
干预措施: Somatotropin (Drug)
结局指标
主要结局
Peak Oxygen Consumption
时间窗: after 48 months
Side effects
时间窗: Any side effects recorded after 6,24 and 48 months
次要结局
- Quality of Life(after 48 months)
- Left Ventricular Ejection Fraction(after 48 months)
- Left Ventricular End-Systolic Volume(after 48 months)
- Left Ventricular End-Diastolic Volume(after 48 months)
研究者
Antonio Cittadini
Associate Professor
Federico II University
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone DeficiencyAdult Growth Hormone DeficiencyNCT00191360Eli Lilly and Company68
招募中
不适用
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in ChildrenGrowth Hormone DeficiencyIdiopathic Short StatureSmall for Gestational AgeChronic Renal FailureTurner SyndromeNCT01604395LG Chem6,000
招募中
不适用
Efficacy and safety of growth hormone treatment in short children born small for gestational age (IUGR-3 STUDY); Effects of GH-levels on growth, insulin sensitivity and body composition.Small for Gestational Age (SGA), Kinderen met persisterend korte gestalteNL-OMON24733Erasmus Medical Center/ Sophia Children's HospitalPO Box 20603000 CB RotterdamThe NetherlandsTel: +31 10 463 63 63157
尚未招募
不适用
Effects of growth hormone treatment after final height in Prader-Willi SyndromePrader-Willi SyndromePrader-Willi SyndroomNL-OMON28633Dutch Growth Foundation20
招募中
3 期
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone DeficiencyMild Traumatic Brain InjuryNCT04867317VA Office of Research and Development172