NCT03775993

Treatment of GHD Associated With CHF

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Heart Failure
• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Human growth hormone	Administration of growth hormone
OTHER	Placebo	Administration of placebo

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2018-12-14
• Last updated: 2019-02-15