NCT01049646

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 10, 2010

Status Verified

August 1, 2010

Enrollment Period

3 months

First QC Date

January 13, 2010

Last Update Submit

August 9, 2010

Conditions

Keywords

renin-angiotensin systemapelinsystemic haemodynamics

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    90 mins

Secondary Outcomes (1)

  • Systemic haemodynamics

    90mins

Study Arms (2)

Angiotensin II

ACTIVE COMPARATOR
Drug: Angiotensin II

Saline infusion

PLACEBO COMPARATOR
Drug: Saline

Interventions

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.

Angiotensin II
SalineDRUG

Infusion of saline. Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.

Saline infusion

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old
  • Healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

  • Barnes GD, Alam S, Carter G, Pedersen CM, Lee KM, Hubbard TJ, Veitch S, Jeong H, White A, Cruden NL, Huson L, Japp AG, Newby DE. Sustained cardiovascular actions of APJ agonism during renin-angiotensin system activation and in patients with heart failure. Circ Heart Fail. 2013 May;6(3):482-91. doi: 10.1161/CIRCHEARTFAILURE.111.000077. Epub 2013 Mar 21.

MeSH Terms

Interventions

Angiotensin IISodium Chloride

Intervention Hierarchy (Ancestors)

AngiotensinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsAutacoidsInflammation MediatorsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 10, 2010

Record last verified: 2010-08

Locations