NCT05277415

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2014

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

January 25, 2022

Last Update Submit

October 21, 2024

Conditions

Heart Failure With Reduced Ejection Fraction HFrEF

Keywords

cardiac output

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in endothelial function between treament groups

    Procedure (At the end of ghrelin administration)

  • Change in cardiac function between treament groups

    Procedure (At the end of ghrelin administration)

  • GH biomarker

    Procedure (At the end of ghrelin administration)

  • ghrelin biomarker

    Procedure (At the end of ghrelin administration)

Study Arms (2)

Ghrelin infusion

ACTIVE COMPARATOR

Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes

Biological: Ghrelin

Placebo

PLACEBO COMPARATOR

Saline 0.50 ml/min during 120 minutes

Biological: Placebo

Interventions

GhrelinBIOLOGICAL

Ghrelin infusion

Ghrelin infusion
PlaceboBIOLOGICAL

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth men and women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lund LH, Hage C, Pironti G, Thorvaldsen T, Ljung-Faxen U, Zabarovskaja S, Shahgaldi K, Webb DL, Hellstrom PM, Andersson DC, Stahlberg M. Acyl ghrelin improves cardiac function in heart failure and increases fractional shortening in cardiomyocytes without calcium mobilization. Eur Heart J. 2023 Jun 9;44(22):2009-2025. doi: 10.1093/eurheartj/ehad100.

    PMID: 36916707DERIVED

MeSH Terms

Interventions

Ghrelin

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind, randomized, parallellel intervention study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 25, 2022

First Posted

March 14, 2022

Study Start

February 17, 2013

Primary Completion

May 22, 2014

Study Completion

May 22, 2014

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share