Interaction of Apelin and Angiotensin in the Systemic Circulation

August 9, 2010 updated by: University of Edinburgh

The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Apelin improves that pumping ability of the heart and we wish to know if this action persists in the presence of increased levels of angiotensin II.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • > 18 years old
  • Healthy volunteers

Exclusion Criteria:

  • Lack of informed consent
  • Age < 18 years,
  • Current involvement in other research studies,
  • Systolic blood pressure >190 mmHg or <100 mmHg
  • Malignant arrhythmias
  • Renal or hepatic failure
  • Haemodynamically significant aortic stenosis
  • Severe or significant co morbidity
  • Women of childbearing potential.

Any regular medication

  • Previous history of any cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Angiotensin II
Drug: Angiotensin II
Infusion of a subpressor dose of angiotensin II will be give, this will be 0.5microG/min/kg. Thereafter thre ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.
Placebo Comparator: Saline infusion
Drug: Saline
Infusion of saline. Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac output
Time Frame: 90 mins
90 mins

Secondary Outcome Measures

Outcome Measure
Time Frame
Systemic haemodynamics
Time Frame: 90mins
90mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 9, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FS/09/019/26905 - 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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