Heart FailureINO-apelinNCT01179061
Investigating the Inotropic Potential of Apelin
A study testing Apelin in people with Heart Failure, run by University of Edinburgh at 3 sites in United Kingdom.
Trial summary
The apelin-APJ system is a recently discover hormone system that has several important actions in the cardiovascular system. Apelin causes the heart pump with more force and also causes blood vessels to relax. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Apelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Aug 2010to Jul 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- >18yrs
- Heart failure patients;
- New York Heart Failure class II-IV
- Ejection fractional <35% or fractional shortening <20% within previous 6months.
Who cannot join
- All subjects,
- Females of child bearing age not on adequate contraception
- Lack of informed consent
- Age <18yrs
- Current involvement in any other research study
- Systolic BP >190 or <100
Show all 14Show fewer
- Malignant arrhythmias
- Renal or hepatic failure
- Haemodynamically significant aortic stenosis
- Severe or significant co-morbidity
- Pacemakers
- Healthy volunteers
- Any regular medication
- Previous history of any cardiovascular disease
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
Edinburgh, EH16 4SA
Gareth Barnes
Edinburgh, EH16 4SA
University of Edinburgh
Edinburgh, EH16 4SA
About this study
Official title: Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure
The apelin-APJ system is a recently discover hormone system that has several important actions in the cardiovascular system. Apelin causes the heart pump with more force and also causes blood vessels to relax. Studies to date show that people with reduced pumping function of the heart have lower levels of apelin in the bloodstream compared to people with normal heart function. We have previously given apelin to healthy volunteers and people with reduced pumping function and this increases the heart's contraction. However, this has only been assessed over a short time period, around fifteen minutes, and we now want to know if this effect is seen over a longer period.
- Conditions
- Heart Failure
- Being tested
- Apelin, Placebo
- Keywords
- Apelin, Heart failure, Pulmonary artery pressure, Inotropic, Diuretic
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApelinDrug
Cardiac index will be assess in patients through the 6hr infusion, using thoracic cardiac bioimpedance. Prior to starting the infusion there will be a 30 minute run in period to achieve a stable cardiac index. Thereafter the infusion will be started, with cardiac index assess every five minutes during the first hour. For each subsequent hour participants will be free to mobilise for the thirty minute periods, with cardiac index and systemic haemodynmics assess for the following thirty minutes.
Additionally during the first hour pulmonary artery pressure will be estimated from pulmonary artery pressures assessed with echocardiography. This will be assessed at baseline with four further measurements during the first hour of infusion.
Participants will be asked to void prior to the study starting, thereafter all urine will be collected during the course of the study. Relevant biochemical/humoral factors will be assessed in the urine.
PlaceboDrug
As per apelin arm, however we will use a saline placebo infusion. All other aspects will remain the same.
| Study group | Role | What they receive |
|---|---|---|
| Apelin infusion | Experimental | 6 hour infusion of apelin peptide into circulation Receives: Drug: Apelin |
| Placebo | Placebo comparator | Infusion of saline into systemic circulation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output
We will assess, using thoracic bioimpedance cardiography, the change in cardiac output in response to apelin infusion
Measured: 6 hours
Secondary outcomes (2)
Urine volume
All urine will be collected during the studya and we will assess volume and relevant biochemical/humoral factors
Measured: 6 hours
Pulmonary artery pressure
Using echocardiography we will estimate the pulmaonary artery pressure from pulmonary velocity and assess any change during the first hour of study.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionJul 2012
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 FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179061
- Sponsor's protocol ID
- 10/S1101/18
- Acronym
- INO-apelin
- Status last verified
- Aug 2010
- First submitted
- 9 Aug 2010
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure
- ClinicalTrials.gov ID
- NCT01179061
- Acronym / sponsor ID
- INO-apelin / 10/S1101/18
- Conditions
- Heart Failure
- Keywords
- Apelin, Heart failure, Pulmonary artery pressure, Inotropic, Diuretic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Aug 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 recently discover hormone system that has several important actions in the cardiovascular system. Apelin causes the heart pump with more force and also causes blood vessels to relax. Studies to date show that people with reduced pumping function of the heart have lower levels of apelin in the bloodstream compared to people with normal heart function. We have previously given apelin to healthy volunteers and people with reduced pumping function and this increases the heart's contraction. However, this has only been assessed over a short time period, around fifteen minutes, and we now want to know if this effect is seen over a longer period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apelin infusion | Experimental | Drug: Apelin6 hour infusion of apelin peptide into circulation |
| Placebo | Placebo comparator | Drug: PlaceboInfusion of saline into systemic circulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18yrs
- Heart failure patients;
- New York Heart Failure class II-IV
- Ejection fractional <35% or fractional shortening <20% within previous 6months.
Key exclusion criteria (14 listed)
- All subjects,
- Females of child bearing age not on adequate contraception
- Lack of informed consent
- Age <18yrs
- Current involvement in any other research study
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 |
|---|---|---|
| ApelinCardiac index will be assess in patients through the 6hr infusion, using thoracic cardiac bioimpedance. Prior to starting the infusion there will be a 30 minute run in period to achieve a stable cardiac index. Thereafter the infusion will be started, with cardiac index assess every five minutes during the first hour. For each subsequent hour participants will be free to mobilise for the thirty minute periods, with cardiac index and systemic haemodynmics assess for the following thirty minutes. Additionally during the first hour pulmonary artery pressure will be estimated from pulmonary artery pressures assessed with echocardiography. This will be assessed at baseline with four further measurements during the first hour of infusion. Participants will be asked to void prior to the study starting, thereafter all urine will be collected during the course of the study. Relevant biochemical/humoral factors will be assessed in the urine. | Drug | Apelin infusion |
| PlaceboAs per apelin arm, however we will use a saline placebo infusion. All other aspects will remain the same. | Drug | Placebo |
Primary outcome
cardiac output
Time frame: 6 hours
We will assess, using thoracic bioimpedance cardiography, the change in cardiac output in response to apelin infusion
2 secondary outcomes
Urine volume
Time frame: 6 hours
Pulmonary artery pressure
Time frame: 1 hour
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 9 May 2024.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apelin in people with Heart Failure, run by University of Edinburgh at 3 sites 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 5 inclusion and 14 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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: 6 hours). 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 NCT01179061, 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 9 May 2024.