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OpenTrials
Completed

NCT Number: NCT05277415

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ghrelin

Biological

Ghrelin infusion

Placebo

Biological

Placebo

Primary outcomes

  1. Change in cardiac output between treament groups

    Time frame: Procedure (At the end of ghrelin administration)

    Assessed by non-invasive inert gas rebreathing technique (L/min)

Secondary outcomes

  1. Change in endothelial function between treament groups

    Time frame: Procedure (At the end of ghrelin administration)

    Assessed non-invasive by flow mediated dilatory capability of the brachial artery (mm)

  2. Change in cardiac function between treament groups

    Time frame: Procedure (At the end of ghrelin administration)

    Assessed by echocardiography (left ventricular ejection fraction, strain, TAPSE)

  3. GH biomarker

    Time frame: Procedure (At the end of ghrelin administration)

    Circulating biomarkers (GH)

  4. ghrelin biomarker

    Time frame: Procedure (At the end of ghrelin administration)

    Circulating biomarkers ( ghrelin)

Sponsors and collaborators

Lead sponsor

Lars Lund

Other

Registry information

Official study title

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

Acronym: MetAnEnd-HF

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2022
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.