Heart DiseaseNCT00901719
Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation
A study testing Apelin, Acetylcholine and Sodium nitroprusside in people with Heart Disease and Heart Failure, 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 months to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Heart Failure, Vasodilatation
- What is being tested?
- Apelin, Acetylcholine and Sodium nitroprusside
- Type of treatment
- Pill or oral medicine, 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
- Apr 2010to May 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 months to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- >18yr
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 Systemic Angiotensin II Peripheral Resistance Vessels and Systemic Haemodynamics 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.
Two of the main actions of apelin are to increase the pumping ability of the heart and cause blood vessels to relax. The investigators wish to assess if these actions are altered in the setting of normal renin-angiotensin activation and increased renin-angiotensin activity.
- Conditions
- Heart Disease, Heart Failure, Vasodilatation
- Being tested
- Apelin, Acetylcholine, Sodium nitroprusside, Systemic apelin infusion
- Keywords
- Renin angiotensin system, Apelin, Cardiac output, Vasodilatation
- Medical subject headings
- Heart Diseases, Heart Failure, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApelinDrug
Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial apelin infusions at 0.3, 1.0 and 3.0 nanomol/ml.
AcetylcholineDrug
Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 5, 10 and 20 microg/min
Sodium nitroprussideDrug
Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 1, 2 and 4 microg/min
Systemic apelin infusionDrug
Following plethysmography patients will receive systemic infusion of (Pry)Apelin-13 (30, 100 and 300 nmol/min) for 5 mins cardiac output, blood pressure, heart rate and systemic vascular resistance will be measured at 5-min intervals.
| Study group | Role | What they receive |
|---|---|---|
| Sodium depletion | Experimental | Subjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing >2000 kcal of energy, >60 g of protein, <12 mmol of sodium and <70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system. Receives: Drug: Apelin; Drug: Acetylcholine; Drug: Sodium nitroprusside; Drug: Systemic apelin infusion |
| Normal diet | Placebo comparator | Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study. Receives: Drug: Apelin; Drug: Acetylcholine; Drug: Sodium nitroprusside; Drug: Systemic apelin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output
Measured: 12 months
Change in apelin mediated vasodilatation
Measured: 12 months
Secondary outcomes (2)
Change in systemic haemodynamics
Measured: 12 months
Change in relevant neurohumoral hormones
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 startApr 2010
- Primary completionMay 2010
- Study completionMay 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 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, British Heart Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901719
- Sponsor's protocol ID
- FS/09/019/26905 - 3
- Status last verified
- May 2009
- First submitted
- 13 May 2009
- 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
- Investigating the Interaction of Apelin and Systemic Angiotensin II Peripheral Resistance Vessels and Systemic Haemodynamics in Vivo in Man
- ClinicalTrials.gov ID
- NCT00901719
- Acronym / sponsor ID
- FS/09/019/26905 - 3
- Conditions
- Heart Disease, Heart Failure, Vasodilatation
- Keywords
- Renin angiotensin system, Apelin, Cardiac output, Vasodilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, British Heart Foundation
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 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.
Two of the main actions of apelin are to increase the pumping ability of the heart and cause blood vessels to relax. The investigators wish to assess if these actions are altered in the setting of normal renin-angiotensin activation and increased renin-angiotensin activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium depletion | Experimental | Drug: Apelin, Drug: Acetylcholine, Drug: Sodium nitroprusside, Drug: Systemic apelin infusionSubjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing >2000 kcal of energy, >60 g of protein, <12 mmol of sodium and <70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system. |
| Normal diet | Placebo comparator | Drug: Apelin, Drug: Acetylcholine, Drug: Sodium nitroprusside, Drug: Systemic apelin infusionSubjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study. |
Who may qualify
- Ages
- 18 months to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- >18yr
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 |
|---|---|---|
| ApelinUsing the technique of venous occlusive plethysmography subjects will receive three intrabrachial apelin infusions at 0.3, 1.0 and 3.0 nanomol/ml. | Drug | Normal diet, Sodium depletion |
| AcetylcholineUsing the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 5, 10 and 20 microg/min | Drug | Normal diet, Sodium depletion |
| Sodium nitroprussideUsing the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 1, 2 and 4 microg/min | Drug | Normal diet, Sodium depletion |
| Systemic apelin infusionFollowing plethysmography patients will receive systemic infusion of (Pry)Apelin-13 (30, 100 and 300 nmol/min) for 5 mins cardiac output, blood pressure, heart rate and systemic vascular resistance will be measured at 5-min intervals. | Drug | Normal diet, Sodium depletion |
Primary outcome
Change in cardiac output
Time frame: 12 months
Change in apelin mediated vasodilatation
Time frame: 12 months
2 secondary outcomes
Change in systemic haemodynamics
Time frame: 12 months
Change in relevant neurohumoral hormones
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.
- 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 Apelin, Acetylcholine and Sodium nitroprusside in people with Heart Disease and Heart Failure, 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 1 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?
Change in cardiac output (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT00901719, 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.