The Effects of C-type Natriuretic Peptide on Human Forear... | NCT01075776

Studies
The Effects of C-type Natriuretic Peptide on Human Forearm Blood Vessels

NCT01075776

Sponsor

Queen Mary University of London

Status

Withdrawn

Last Update Posted

May 5, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Ischaemia-reperfusion (IR) Injury

Interventions

C-type natriuretic peptide (CNP)
Saline
Acetylcholine

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

May 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Jan 2020Estimated

Primary Completion Date

Jan 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Feb 23, 2010

First Submission Date that Met QC Criteria

Feb 24, 2010

First Posted Date

Feb 25, 2010Estimated

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

May 3, 2020

Last Update Posted Date

May 5, 2020Actual

Name	Class
University College, London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

To determine the effects of whether increasing CNP concentrations slightly above normal will improve the functioning of blood vessels after the interruption in the flow of blood. In this study we are looking at the function of the blood vessels of the forearm, as a substitute for those in the heart

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CNP	Experimental	Infusion of CNP prior to IR injury	Drug: C-type natriuretic peptide (CNP) Drug: Acetylcholine
Saline	Placebo Comparator	Effect of saline infusion prior to IR injury	Drug: Saline Drug: Acetylcholine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-type natriuretic peptide (CNP)	Drug	360 pmol/min for 15 minutes intra-arterially	CNP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in area under curve dose-response to acetylcholine after IR injury		2h

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy human volunteers on no systemic medication, excepting the oral contraceptive pill

Exclusion Criteria:

History of medical illness
Unwillingness to sign consent form
Use of non-OCP medications
Hypertension on examination of the blood pressure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahluwalia Amrita, BSc PhD	Queen Mary University London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary University London		London		EC1M 6BQ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020098	Natriuretic Peptide, C-Type
D012965	Sodium Chloride
D000109	Acetylcholine

Ancestor Terms

ID	Term
D045265	Natriuretic Peptides
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided