Heart DiseaseNCT00901745
Interaction of Apelin and Angiotensin in the Human Forearm Circulation
A study testing Angiotensin II and Noradrenaline infusion in people with Heart Disease and Vasodilation, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Vasodilation
- What is being tested?
- Angiotensin II and Noradrenaline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years old
- Healthy volunteers
Who cannot join
- 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
Show all 11Show fewer
- Haemodynamically significant aortic stenosis
- Severe or significant co morbidity
- Women of childbearing potential.
- Any regular medication
- Previous history of any cardiovascular disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
Edinburgh, EH16 4SA
About this study
Official title: Investigating the Interaction of Apelin and Angiotensin II Peripheral Resistance Vessels in Vivo in Man
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 has the ability to cause blood vessels to relax, increasing their diameter and hence blood flow down the blood vessel. The researchers wish to investigate the hypothesis that an infusion of apelin will reduce the effects of angiotensin II, which is know to reduce the diameter of blood vessels.
- Conditions
- Heart Disease, Vasodilation
- Being tested
- Angiotensin II, Noradrenaline infusion
- Keywords
- Renin angiotensin system, Apelin, Vasodilatation, Heart disease, Vascular biology
- Medical subject headings
- Heart Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin IIDrug
Infusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed.
Noradrenaline infusionDrug
Infusion of up to 480 picomol/ml of noradrenaline will be infused.
| Study group | Role | What they receive |
|---|---|---|
| Infusion of apelin | Experimental | Using forearm venous occlusion plethysmography apelin will be infused to cause reduction in forearm blood flow. Infusion of angiotensin II and noradrenaline will given and vasoconstriction will be assessed. Blood samples for the infused arm and contra-lateral arm will be taken at regular time points to assess local and systemic changes in relevant hormones. Receives: Drug: Angiotensin II; Drug: Noradrenaline infusion |
| Sodium nitroprusside infusion | Active comparator | Using forearm venous occlusion plethysmography sodium nitroprusside will be infused to cause reduction in forearm blood flow. Infusion of angiotensin II and noradrenaline will given and vasoconstriction will be assessed. Blood samples for the infused arm and contra-lateral arm will be taken at regular time points to assess local and systemic changes in relevant hormones. Receives: Drug: Angiotensin II; Drug: Noradrenaline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in angiotensin II mediated vasoconstriction
Measured: 12 months
Secondary outcomes (1)
Changes in relevant neurohumoral hormones in response to apelin infusion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Investigators
- Gareth D Barnes, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901745
- Sponsor's protocol ID
- FS/09/019/26905 - 1b
- Status last verified
- May 2009
- First submitted
- 13 May 2009
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Interaction of Apelin and Angiotensin II Peripheral Resistance Vessels in Vivo in Man
- ClinicalTrials.gov ID
- NCT00901745
- Acronym / sponsor ID
- FS/09/019/26905 - 1b
- Conditions
- Heart Disease, Vasodilation
- Keywords
- Renin angiotensin system, Apelin, Vasodilatation, Heart disease, Vascular biology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 has the ability to cause blood vessels to relax, increasing their diameter and hence blood flow down the blood vessel. The researchers wish to investigate the hypothesis that an infusion of apelin will reduce the effects of angiotensin II, which is know to reduce the diameter of blood vessels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infusion of apelin | Experimental | Drug: Angiotensin II, Drug: Noradrenaline infusionUsing forearm venous occlusion plethysmography apelin will be infused to cause reduction in forearm blood flow. Infusion of angiotensin II and noradrenaline will given and vasoconstriction will be assessed. Blood samples for the infused arm and contra-lateral arm will be taken at regular time points to assess local and systemic changes in relevant hormones. |
| Sodium nitroprusside infusion | Active comparator | Drug: Angiotensin II, Drug: Noradrenaline infusionUsing forearm venous occlusion plethysmography sodium nitroprusside will be infused to cause reduction in forearm blood flow. Infusion of angiotensin II and noradrenaline will given and vasoconstriction will be assessed. Blood samples for the infused arm and contra-lateral arm will be taken at regular time points to assess local and systemic changes in relevant hormones. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years old
- Healthy volunteers
Key exclusion criteria (11 listed)
- Lack of informed consent
- Age < 18 years,
- Current involvement in other research studies,
- Systolic blood pressure >190 mmHg or <100 mmHg
- Malignant arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin IIInfusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed. | Drug | Infusion of apelin, Sodium nitroprusside infusion |
| Noradrenaline infusionInfusion of up to 480 picomol/ml of noradrenaline will be infused. | Drug | Infusion of apelin, Sodium nitroprusside infusion |
Primary outcome
Change in angiotensin II mediated vasoconstriction
Time frame: 12 months
1 secondary outcome
Changes in relevant neurohumoral hormones in response to apelin infusion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth D Barnes, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiotensin II and Noradrenaline infusion in people with Heart Disease and Vasodilation, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in angiotensin II mediated vasoconstriction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.