NCT02129179

Brief Summary

This study aims to assess the effect of glucagon-like peptide-1 on cardiac output and transpulmonary gradient in patients undergoing right heart catheterisation for clinical reasons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline
Completed

Started Jun 2014

Typical duration for phase_1 heart-failure

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

2.5 years

First QC Date

April 30, 2014

Last Update Submit

April 3, 2018

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Change in Pulmonary Vascular Resistance with Glucagon-Like Peptide-1

    30 minutes

Study Arms (1)

GLP-1

EXPERIMENTAL
Drug: Glucagon-Like Peptide 1

Interventions

Glucagon-Like Peptide 1DRUG
GLP-1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • Able to give informed consent
  • On the waiting list for heart transplant
  • Left Ventricular Dysfunction awaiting catheterisation

You may not qualify if:

  • Nicorandil, glibenclamide, Dipeptidyl Peptidase-4 inhibitor, Glucagon-Like Peptide-1 receptor agonist or insulin
  • Women of child bearing age and breast feeding women
  • Cardiac pacemaker or other implanted metallic device
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Papworth Everard, CB23 3RE, United Kingdom

Location

Related Publications (1)

  • Clarke SJ, Pettit S, Giblett JP, Zhao T, Kydd AC, Albrechtsen NJW, Deacon CF, Parameshwar J, Hoole SP. Effects of Acute GLP-1 Infusion on Pulmonary and Systemic Hemodynamics in Patients With Heart Failure: A Pilot Study. Clin Ther. 2019 Jan;41(1):118-127.e0. doi: 10.1016/j.clinthera.2018.11.013. Epub 2018 Dec 28.

    PMID: 30598343DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 2, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

GB(1)