Treatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study - Treatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-B

AOU FEDERICO II0 个研究点目标入组 64 人开始时间: 2021年6月1日最近更新: 2022年4月4日

适应症

试验速览

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•1)patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;
•2)age range 18-85 years;
•3)stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);
•4)LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;
•5)GH deficiency diagnosed with GHRH + arginine provocative test;
•6)signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

•1)inability to perform a bicycle exercise test;
•2)poorly controlled diabetes mellitus (HbA1c >8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;
•3)active and/or history of malignancy: there is no evidence that GH replacement in adults increases the risk of de novo or recurrent malignancy. GH will not be initiated in patients with active neoplasm, either newly diagnosed or recurrent as well as in subjects with a history of cancer shorter than one year. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors will be ruled out prior to initiation of treatment. GH therapy will not be used in patients with any evidence of progression or recurrence of an underlying intracranial space-occupying lesion.
•4)unstable angina or recent myocardial infarction (less than six months);
•5)severe liver or kidney disease (serum creatinine levels >2.5 mg/dl)
•6)patients with acute critical illnesses caused by complications of open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
•7)active infection or sepsis.
•8)any allergies to growth hormone, or other ingredients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or metacresol

发起方

AOU FEDERICO II