Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure

Study Overview
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Brief Summary
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In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion

Detailed Description
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In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion (single dose). The following parameters will be collected: routine clinical parameters, endothelial function, cardiac structure and function by echocardiography, non-invasively assessed cardiac output and hemodynamics, serologic and of cardiac and renal function, sympathetic and RAS activation, metabolism, anabolic hormone function, inflammation, fibrosis, oxidative stress and apoptosis. 15 patients each group in are adequate to detect a difference between groups and before vs after ghrelin administration in metabolism, anabolic function and endothelial function with a power of 90% and two-sided significance of 5%.

Official Title
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Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Herat Failure

Conditions
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Heart Failure With Reduced Ejection Fraction HFrEF

Intervention / Treatment
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* Biological: Ghrelin
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current or past signs of clinical HF according to the Framingham criteria LVEF<40% NT-proBNP > 300 ng/L Exclusion Criteria: Inability to or unwillingness to provide informed consent, Participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.

Ages Eligible for Study
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Minimum Age: 18 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, randomized, parallellel intervention study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ghrelin infusion<br>Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes | Biological: Ghrelin<br>* Ghrelin infusion<br>|
| Placebo Comparator: Placebo<br>Saline 0.50 ml/min during 120 minutes | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac output between treament groups | Assessed by non-invasive inert gas rebreathing technique (L/min) | Procedure (At the end of ghrelin administration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endothelial function between treament groups | Assessed non-invasive by flow mediated dilatory capability of the brachial artery (mm) | Procedure (At the end of ghrelin administration) | 
| Change in cardiac function between treament groups | Assessed by echocardiography (left ventricular ejection fraction, strain, TAPSE) | Procedure (At the end of ghrelin administration) | 
| GH biomarker | Circulating biomarkers (GH) | Procedure (At the end of ghrelin administration) | 
| ghrelin biomarker | Circulating biomarkers ( ghrelin) | Procedure (At the end of ghrelin administration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac output