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

October 21, 2024 updated by: Lars Lund

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Procedure (At the end of ghrelin administration)
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
Time Frame: Procedure (At the end of ghrelin administration)
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
Time Frame: Procedure (At the end of ghrelin administration)
Assessed by echocardiography (left ventricular ejection fraction, strain, TAPSE)
Procedure (At the end of ghrelin administration)
GH biomarker
Time Frame: Procedure (At the end of ghrelin administration)
Circulating biomarkers (GH)
Procedure (At the end of ghrelin administration)
ghrelin biomarker
Time Frame: Procedure (At the end of ghrelin administration)
Circulating biomarkers ( ghrelin)
Procedure (At the end of ghrelin administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Lund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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