NCT01075776

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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
9.9 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

February 23, 2010

Last Update Submit

May 3, 2020

Conditions

Ischaemia-reperfusion (IR) Injury

Outcome Measures

Primary Outcomes (1)

  • Change in area under curve dose-response to acetylcholine after IR injury

    2h

Study Arms (2)

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: SalineDrug: Acetylcholine

Interventions

C-type natriuretic peptide (CNP)DRUG

360 pmol/min for 15 minutes intra-arterially

CNP
SalineDRUG

Sodium Chloride 0.9% intra-arterially 0.5ml/min

Saline
AcetylcholineDRUG

2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb

CNPSaline

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University London

London, EC1M 6BQ, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Natriuretic Peptide, C-TypeSodium ChlorideAcetylcholine

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsBiogenic AminesAminesOrganic Chemicals

Study Officials

  • Ahluwalia Amrita, BSc PhD

    Queen Mary University London

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Vascular Pharmacology

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 25, 2010

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations

GB(1)