Back to resultsThe Effects of C-type Natriuretic Peptide on Human Forearm Blood Vessels
Primary Purpose
Ischaemia-reperfusion (IR) Injury
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
C-type natriuretic peptide (CNP)
Saline
Acetylcholine
Sponsored by
About this trial
This is an interventional basic science trial for Ischaemia-reperfusion (IR) Injury
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
Sites / Locations
- Queen Mary University London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CNP
Saline
Arm Description
Infusion of CNP prior to IR injury
Effect of saline infusion prior to IR injury
Outcomes
Primary Outcome Measures
Change in area under curve dose-response to acetylcholine after IR injury
Secondary Outcome Measures
Full Information
NCT ID
NCT01075776
First Posted
February 23, 2010
Last Updated
May 3, 2020
Sponsor
Queen Mary University of London
Collaborators
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT01075776
Brief Title
The Effects of C-type Natriuretic Peptide on Human Forearm Blood Vessels
Official Title
The Effects of C-type Natriuretic Peptide on Endothelial Function Following Ischaemia-Reperfusion in the Human Forearm
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Mary University of London
Collaborators
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemia-reperfusion (IR) Injury
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNP
Arm Type
Experimental
Arm Description
Infusion of CNP prior to IR injury
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Effect of saline infusion prior to IR injury
Intervention Type
Drug
Intervention Name(s)
C-type natriuretic peptide (CNP)
Intervention Description
360 pmol/min for 15 minutes intra-arterially
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Sodium Chloride 0.9% intra-arterially 0.5ml/min
Intervention Type
Drug
Intervention Name(s)
Acetylcholine
Intervention Description
2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb
Primary Outcome Measure Information:
Title
Change in area under curve dose-response to acetylcholine after IR injury
Time Frame
2h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahluwalia Amrita, BSc PhD
Organizational Affiliation
Queen Mary University London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary University London
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Effects of C-type Natriuretic Peptide on Human Forearm Blood Vessels
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