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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Queen Mary University of London
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Amrita Ahluwalia, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01075776
First received: February 23, 2010
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Ischaemia-reperfusion (IR) Injury
Drug: C-type natriuretic peptide (CNP)
Drug: Saline
Drug: Acetylcholine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effects of C-type Natriuretic Peptide on Endothelial Function Following Ischaemia-Reperfusion in the Human Forearm

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Change in area under curve dose-response to acetylcholine after IR injury [ Time Frame: 2h ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNP
Infusion of CNP prior to IR injury
Drug: C-type natriuretic peptide (CNP)
360 pmol/min for 15 minutes intra-arterially
Drug: Acetylcholine
2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb
Placebo Comparator: Saline
Effect of saline infusion prior to IR injury
Drug: Saline
Sodium Chloride 0.9% intra-arterially 0.5ml/min
Drug: Acetylcholine
2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075776

Contacts
Contact: Ahluwalia A, BSc PhD 020 7882 8317 a.ahluwalia@qmul.ac.uk

Locations
United Kingdom
Queen Mary University London Not yet recruiting
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Queen Mary University of London
University College, London
Investigators
Principal Investigator: Ahluwalia Amrita, BSc PhD Queen Mary University London
  More Information

No publications provided

Responsible Party: Amrita Ahluwalia, Professor of Vascular Pharmacology, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01075776     History of Changes
Other Study ID Numbers: 007143
Study First Received: February 23, 2010
Last Updated: September 24, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Ischemia
Wounds and Injuries
Pathologic Processes
Acetylcholine
Natriuretic Peptide, C-Type
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Natriuretic Agents

ClinicalTrials.gov processed this record on August 21, 2014