Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Administration of growth hormone
Administration of placebo
Change of peak oxygen consumption (peak VO2)
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
Time frame: 1 year
Number of Hospitalizations
Time frame: 1 year
End-systolic LV volumes
Time frame: 1 year
NT-proBNP levels
Time frame: 1 year
Quality of life score from the Minnesota Living with Heart Failure Questionnaire
The questionnaire is comprised of 21 physical, emotional and socioeconomic questions that may adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (lower valure) to 5 (upper value) scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The final score is calculated by sum.
Time frame: 1 year
Evaluation of Endothelial function (flow-mediated vasodilation)
Time frame: 1 year
Muscle strength (handgrip)
Time frame: 1 year
Evaluation of the Levels of Endothelial Progenitor Cells (EPCs)
Time frame: 1 year
Evaluation of the Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.