Renin Angiotensin SystemNCT01049646
Interaction of Apelin and Angiotensin in the Systemic Circulation
A study testing Angiotensin II and Saline in people with Renin Angiotensin System, 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 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renin Angiotensin System
- What is being tested?
- Angiotensin II and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to 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
- Men only
- 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
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.
- Conditions
- Renin Angiotensin System
- Being tested
- Angiotensin II, Saline
- Keywords
- renin-angiotensin system, apelin, systemic haemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin IIDrug
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.
SalineDrug
Infusion of saline. Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Angiotensin II | Active comparator | Not described Receives: Drug: Angiotensin II |
| Saline infusion | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Measured: 90 mins
Secondary outcomes (1)
Systemic haemodynamics
Measured: 90mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renin Angiotensin SystemStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049646
- Sponsor's protocol ID
- FS/09/019/26905 - 2
- Status last verified
- Aug 2010
- First submitted
- 13 Jan 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23519586
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
- Interaction of Apelin and Angiotensin in the Systemic Circulation
- ClinicalTrials.gov ID
- NCT01049646
- Acronym / sponsor ID
- FS/09/019/26905 - 2
- Conditions
- Renin Angiotensin System
- Keywords
- renin-angiotensin system, apelin, systemic haemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Jan 2010 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiotensin II | Active comparator | Drug: Angiotensin II |
| Saline infusion | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- 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 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. | Drug | Angiotensin II |
| SalineInfusion of saline. Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured. | Drug | Saline infusion |
Primary outcome
Cardiac output
Time frame: 90 mins
1 secondary outcome
Systemic haemodynamics
Time frame: 90mins
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.
- Derived from this study: PubMed 23519586Barnes 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Saline in people with Renin Angiotensin System, 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. Some participants in this study may receive a placebo. 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?
Cardiac output (time frame: 90 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049646, which also lists 1 linked publication.
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.