Back to resultsThe Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Glucagon-Like Peptide 1
Sponsored by
About this trial
This is an interventional basic science trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Age over 18
- Able to give informed consent
- On the waiting list for heart transplant
- Left Ventricular Dysfunction awaiting catheterisation
Exclusion Criteria:
- 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
Sites / Locations
- Papworth Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GLP-1
Arm Description
Outcomes
Primary Outcome Measures
Change in Pulmonary Vascular Resistance with Glucagon-Like Peptide-1
Secondary Outcome Measures
Full Information
NCT ID
NCT02129179
First Posted
April 30, 2014
Last Updated
April 3, 2018
Sponsor
Papworth Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02129179
Brief Title
The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure
Official Title
The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Papworth Hospital NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLP-1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Glucagon-Like Peptide 1
Primary Outcome Measure Information:
Title
Change in Pulmonary Vascular Resistance with Glucagon-Like Peptide-1
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18
Able to give informed consent
On the waiting list for heart transplant
Left Ventricular Dysfunction awaiting catheterisation
Exclusion Criteria:
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
Facility Information:
Facility Name
Papworth Hospital NHS Foundation Trust
City
Papworth Everard
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30598343
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure
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