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Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo

Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02150694
Acronym
HEAP
Enrollment
52
Registered
2014-05-30
Start date
2012-01-31
Completion date
2013-08-31
Last updated
2014-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Brief summary

Apelins are substances which occur naturally in the body, and have an important role in heart disease. They have been shown to make blood vessels dilate, and improve the way the heart works. The investigators have devised 2 sets of experiments to investigate how the apelins affect blood vessels. In the first group of experiments,the investigators will give healthy volunteers up to 3 different apelin substances, and use special research techniques to see how they affect the way that blood vessels work in the forearm. In the second group of experiments, the apelins will be given along with another form of apelin which blocks the effects of apelin in laboratory experiments. The investigators want to see if it blocks the effects of apelin in healthy humans. The investigators intend to test the hypothesis that: Apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by an apelin receptor antagonist. This study will help us to understand more about how apelins work, and to suggest how they might be used to treat heart disease.

Interventions

Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.

PROCEDUREAellig hand vein technique

Hand vein measurements will be used to assess the response to apelin peptides and apelin receptor blocker in the human hand vein vascular bed.

OTHERApelin agonist infusion

Escalating doses of apelin (1/10/100nmol/min) will be administered.

OTHERApelin receptor antagonist infusion

Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides

Sponsors

University of Cambridge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Between 18 and 70 years * Non-regular smoking (\<5 cigarettes per week) * If female, postmenopausal or on days 2-9 of menstrual cycle

Exclusion criteria

* Hypertension (sustained BP \>160/100mmHg) * Ischaemic Heart Disease * Renal, respiratory or neurological disease * Diabetes mellitus * BMI \>30, BMI \<18 * Pregnant * Smoker * Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study. * Current involvement in other research studies

Design outcomes

Primary

MeasureTime frame
Forearm blood flow measured by forearm plethysmography in response to infused vasodilators2-3 hours
Change in hand vein diameter measured by Aellig hand vein technique, in response to study peptides2-3 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026