The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonar... | NCT02129179

Studies
The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure

NCT02129179

Sponsor

Papworth Hospital NHS Foundation Trust

Status

Completed

Last Update Posted

Apr 5, 2018Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Heart Failure

Interventions

Glucagon-Like Peptide 1

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Apr 30, 2014

First Submission Date that Met QC Criteria

May 1, 2014

First Posted Date

May 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
GLP-1	Experimental		Drug: Glucagon-Like Peptide 1

Name	Type	Description	Arm Group Labels	Other Names
Glucagon-Like Peptide 1	Drug		GLP-1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Pulmonary Vascular Resistance with Glucagon-Like Peptide-1		30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Papworth Hospital NHS Foundation Trust		Papworth Everard		CB23 3RE	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30598343	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones