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

Phase 1

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction HFrEF
• Interventions: Biological: Ghrelin; Biological: Placebo

• Registration Number: NCT05277415
• Lead Sponsor: Lars Lund

Brief Summary

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

Detailed Description

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%.

Study Timeline

• Study Start: 2013-02-17
• Primary Completion: 2014-05-22
• Study Completion: 2014-05-22
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Current or past signs of clinical HF according to the Framingham criteria
2. LVEF<40%
3. NT-proBNP > 300 ng/L

Exclusion Criteria

1. Inability to or unwillingness to provide informed consent,
2. Participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ghrelin infusion	Ghrelin	Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes
Placebo	Placebo	Saline 0.50 ml/min during 120 minutes

Primary Outcome Measures

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

Secondary Outcome Measures

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