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临床试验/NCT03775993
NCT03775993Unknown3 期

Treatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study

Federico II University0 个研究点目标入组 64 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
64
主要终点
Change of peak oxygen consumption (peak VO2)

研究概览

简要总结

Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF

详细描述

Multiple anabolic deficiencies are common in chronic heart failure (CHF) and identify subgroups of patients with higher mortality. Apart from CHF, GH deficiency (GHD) per se increases cardiovascular mortality in the general population and low IGF-1 levels in the general population predict the development of ischemic heart disease and CHF. GHD modifies cardiac size and function, through a reduction in both myocardial growth and cardiac performance. The investigators therefore completed 2 studies aimed at evaluating the clinical status, neurohormonal parameters, exercise capacity, vascular reactivity, and left ventricular architecture and function in patients with GHD and CHF, at baseline and after 6 months of GH replacement therapy. They subsequently extended the observation period up to 48 months. At 6-months, GH replacement therapy improved clinical status and exercise capacity, as shown by a significant reduction of the Minnesota living with heart failure questionnaire score, increased peak oxygen consumption and exercise duration, and flow mediated vasodilation of the brachial artery. No major adverse events were reported in the patients receiving GH.

However, the encouraging results of these studies are limited by the lack of a double-blind, placebo-controlled design, insofar as the investigators performed a randomized controlled, single-blind study.

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;
  • age range 18-85 years;
  • stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);
  • LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;
  • GH deficiency diagnosed with GHRH + arginine provocative test;
  • signed informed consent.

排除标准

  • inability to perform a bicycle exercise test;
  • poorly controlled diabetes mellitus (HbA1c >8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;
  • active and/or history of malignancy;
  • unstable angina or recent myocardial infarction (less than six months);
  • severe liver or kidney disease (serum creatinine levels >2.5 mg/dl

研究组 & 干预措施

GHD

Active Comparator

干预措施: Human growth hormone (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Change of peak oxygen consumption (peak VO2)

时间窗: 1 year

According to previous observations, the investigators set a target increase of peak VO2 in the treated arm at 3 ml/kg/min at the end of the study

次要结局

  • Number of Hospitalizations(1 year)
  • End-systolic LV volumes(1 year)
  • NT-proBNP levels(1 year)
  • Quality of life score from the Minnesota Living with Heart Failure Questionnaire(1 year)
  • Evaluation of Endothelial function (flow-mediated vasodilation)(1 year)
  • Muscle strength (handgrip)(1 year)
  • Evaluation of the Levels of Endothelial Progenitor Cells (EPCs)(1 year)
  • Evaluation of the Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2(1 year)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Cittadini

Full Professor

Federico II University

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Treatment of GHD Associated With CHF | 临床试验