NCT00552851Unknown4 期
Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant: an Open-labelled, Prospective Study
University of Wuerzburg1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
研究概览
简要总结
The purpose of this study is to evaluate changes in left ventricular mass and cardiac function in patients with active acromegaly before and after treatment with the growth hormone receptor antagonist pegvisomant for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active acromegaly in adult subjects (≥ 18 years) after surgery and/or radiation therapy with elevated IGF-1 levels despite treatment with somatostatin analogues or dopamine agonists
- •Pegvisomant therapy is indicated (i. e. patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapy, or for whom these therapies are not appropriate)
- •Evidence of left ventricular hypertrophy (infero-lateral wall thickness ≥ 12 mm assessed by echocardiography) or
- •Evidence of impaired diastolic function (≥ stage 2 as assessed by echocardiography) or
- •Evidence of systolic dysfunction (Ejection fraction < 50% assessed by echocardiography)
- •Stable medication for arterial hypertension and heart failure for 3 months
- •Written informed consent.
排除标准
- •Pregnancy and lactation period
- •Previous therapy with Pegvisomant
- •Suspected or known hypersensitivity to the drug or any of its components
- •Contraindications for MRI
- •History of malignancy during the last 5 years
- •Suspected or known drug or alcohol abuse
- •Patients who are neither able to self administer study medication on a daily basis nor have a caregiver who can administer study medication to the patient on a daily basis
- •Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion
- •Participation in another clinical trial
- •Pituitary adenoma with a distance to the optic chiasm of < 3 mm
- •Any other drug for treatment of acromegaly (e.g. dopamine agonists, Somatostatin analogues) which would be necessary during the study or patients who apply for radiotherapy
- •Instable heart insufficiency classified as NYHA IV.
- •Severe renal insufficiency, liver transplantation
研究组 & 干预措施
Pegvisomant
Other
patients with active acromegaly and impaired cardiac function
干预措施: pegvisomant (Drug)
结局指标
主要结局
Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
时间窗: one year
次要结局
- Ejection fraction,Enddiastolic thickness of the infero-lateral wall,Diastolic function,Left ventricular mass index,Stroke volume,Ejection fraction (MRI),CO,Late hyperenhancement,IGF-I,insulin sensitivity,Ringsize,adverse events,Endothelial function(one year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Cardiac Function and Microcirculation: Type 2 DIABetes and ECHOcardiographic Changes Over TimeLeft Ventricular DysfunctionNCT02956577Svendborg Hospital300
进行中（未招募）
1 期
CHANGES OF LEFT VENTRICULAR MASS AND CARDIAC FUNCTION IN PATIENTS WITH ACTIVE ACROMEGALY DURING TREATMENT WITH THE GROWTH HORMONE RECEPTOR ANTAGONIST PEGVISOMANT: AN OPEN-LABELLED, PROSPECTIVE STUDY - Pegvisomant cardiac studyEUCTR2006-001108-35-DEClinic of University of Wuerzburg16
已完成
不适用
Peripheral Artery Disease in VastmanlandPeripheral Vascular DiseasesVentricular DysfunctionHeart FailureNCT01452165Uppsala University457
进行中（未招募）
不适用
Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain AmyloidosisAmyloid CardiomyopathyChemotherapy EffectCongestive Heart FailureNCT05452850Istanbul University - Cerrahpasa (IUC)30
已完成
不适用
LV Only MPP With SyncAVLeft Bundle-Branch BlockHeart FailureNCT03567096Abbott Medical Devices101