Heart Failure Clinical Trial
Official title:
Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study
The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.
To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients
with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern
of peripheral resistance to GH, in particular in patients with severe heart failure and
cardiac cachexia. Unpublished experience of our group support the concept that a
considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD),
defined by current guidelines(GH stimulation test).
Our study hypothesis is that correction of GH deficiency in patients with chronic heart
failure may exert a beneficial effect on their cardiac function and remodeling, performance
status and quality-of-life.
Since this was a preliminary study, no sample size calculation was performed; treatment
effects from were sought in left ventricular function (as assessed by cardiac MRI),
cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and
neurohumoral markers of disease (NT-proBNP).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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