Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure (MetAnEnd-HF)

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure With Reduced Ejection Fraction HFrEF
• Intervention / Treatment: Biological: Placebo; Biological: Ghrelin

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ghrelin infusion; Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes	Biological: Ghrelin; Ghrelin infusion
Placebo Comparator: Placebo; Saline 0.50 ml/min during 120 minutes	Biological: Placebo; Placebo

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Lars Lund

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2013
• Primary Completion (Actual): May 22, 2014
• Study Completion (Actual): May 22, 2014

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: cardiac output
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2008/1:12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No