COPDNCT02129309
Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures
A study testing Forearm plethysmography and Haemodynamic studies in people with COPD and Pulmonary Hypertension, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators are interested in studying how Pulmonary Hypertension occurs. A substance called 'apelin', that naturally occurs in the body has been shown to have an important role in heart disease. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Pulmonary Hypertension
- What is being tested?
- Forearm plethysmography and Haemodynamic studies
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Dec 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Aged 18 to 70 years
- Non-smoker (<1 cigarette per week)
- If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test COPD patients with estimated Pulmonary Artery Pressure (PAP) on echo >25mmHg
- Clinical diagnosis of COPD as per standard criteria
- Between 18 and 70 years
- If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test
Who cannot join
- pre-existing:
- Systemic Hypertension (sustained BP >160/100mmHg)
- Ischaemic Heart Disease
- Primary valvular heart disease
- Significant left ventricular failure
- Active malignancy
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- Renal disease (Creatinine >180 µmol/L)
- Neurological disease
- Diabetes mellitus
- BMI >35, BMI <17
- Pregnancy
- Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study.
- Current involvement in other research studies, other than observational/non-interventional
- Known HIV
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Vascular Research Unit, Clinical Pharmacology Unit, ACCI, Level 3, Addenbrooke's Hospital, Hills Road
Cambridge, CB2 0QQ
About this study
Official title: Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures.
The investigators are interested in studying how Pulmonary Hypertension occurs. A substance called 'apelin', that naturally occurs in the body has been shown to have an important role in heart disease. Previous studies have shown that it can make blood vessels get wider, and help blood flow around the body and thus improve the way the heart and lungs work.
The investigators are looking to recruit both healthy and COPD pulmonary hypertension patients to study 3 types of apelin. The purpose of this study is to help the investigators understand how Pulmonary Hypertension occurs which may will help with the development of future treatments.
Read the detailed description
The purpose of this study:
To investigate the physiological role of apelin in the cardiovascular system in patients with COPD with raised pulmonary artery pressures.
Study Aim and hypotheses:
The primary objective is to test the above hypotheses using forearm blood flow and systemic infusions of apelin peptides.
Hypotheses:
- Apelin agonists are vasodilators in human resistance vessels and this effect will be altered in patients with pulmonary hypertension.
- Apelin peptides improve right ventricular and pulmonary haemodynamics in patients with elevated pulmonary artery pressures.
Study 1a - A validation dose study of 3 apelin agonists performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 1b- A validation dose study of apelin receptor antagonist, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 2a - To define the haemodynamic response to apelin agonists in healthy volunteers and evaluate the response.
Study 2b - To investigate the haemodynamic response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures.
- Conditions
- COPD, Pulmonary Hypertension
- Being tested
- Forearm plethysmography, Haemodynamic studies
- Keywords
- COPD, Apelin, agonist, antagonist
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm plethysmographyProcedure or surgery
Dose response study
Haemodynamic studiesProcedure or surgery
Also called Innocor, Bioimpedance, Echocardiography
Dose response study
| Study group | Role | What they receive |
|---|---|---|
| Systemic Apelin infusion | Experimental | Study 2a - Haemodynamic studies to investigate the response to systemic infusions of 3 apelin agonists in healthy volunteers
Study 2b - Haemodynamic studies to investigate the response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures Receives: Procedure: Haemodynamic studies |
| Apelin infusion - forearm | Experimental | Study 1a - A validation dose study of 3 apelin agonists using forearm plethysmography to evaluate changes in forearm blood flow: performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 1b- A validation dose study of apelin receptor antagonist using forearm plethysmography to evaluate changes in forearm blood flow, in healthy volunteers and COPD patients with elevated pulmonary artery pressures. Receives: Procedure: Forearm plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in forearm blood flow in the infused arm. Forearm blood flow ratio in each arm, blood pressure and heart rate will also be reported.
Measured: 12 months
Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate.
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 posted2 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, University of Cambridge
- Responsible party
- Principal investigator, Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Dr. Joseph Cheriyan, MD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129309
- Sponsor's protocol ID
- ALPHa-COPD
- Status last verified
- Jan 2015
- First submitted
- 28 Apr 2014
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures.
- ClinicalTrials.gov ID
- NCT02129309
- Acronym / sponsor ID
- ALPHa-COPD
- Conditions
- COPD, Pulmonary Hypertension
- Keywords
- COPD, Apelin, agonist, antagonist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Wellcome Trust, University of Cambridge
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 May 2014 (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 investigators are interested in studying how Pulmonary Hypertension occurs. A substance called 'apelin', that naturally occurs in the body has been shown to have an important role in heart disease. Previous studies have shown that it can make blood vessels get wider, and help blood flow around the body and thus improve the way the heart and lungs work.
The investigators are looking to recruit both healthy and COPD pulmonary hypertension patients to study 3 types of apelin. The purpose of this study is to help the investigators understand how Pulmonary Hypertension occurs which may will help with the development of future treatments.
Detailed description
The purpose of this study:
To investigate the physiological role of apelin in the cardiovascular system in patients with COPD with raised pulmonary artery pressures.
Study Aim and hypotheses:
The primary objective is to test the above hypotheses using forearm blood flow and systemic infusions of apelin peptides.
Hypotheses:
- Apelin agonists are vasodilators in human resistance vessels and this effect will be altered in patients with pulmonary hypertension.
- Apelin peptides improve right ventricular and pulmonary haemodynamics in patients with elevated pulmonary artery pressures.
Study 1a - A validation dose study of 3 apelin agonists performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 1b- A validation dose study of apelin receptor antagonist, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 2a - To define the haemodynamic response to apelin agonists in healthy volunteers and evaluate the response.
Study 2b - To investigate the haemodynamic response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Apelin infusion | Experimental | Procedure: Haemodynamic studiesStudy 2a - Haemodynamic studies to investigate the response to systemic infusions of 3 apelin agonists in healthy volunteers Study 2b - Haemodynamic studies to investigate the response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures |
| Apelin infusion - forearm | Experimental | Procedure: Forearm plethysmographyStudy 1a - A validation dose study of 3 apelin agonists using forearm plethysmography to evaluate changes in forearm blood flow: performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures. Study 1b- A validation dose study of apelin receptor antagonist using forearm plethysmography to evaluate changes in forearm blood flow, in healthy volunteers and COPD patients with elevated pulmonary artery pressures. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy volunteers
Key exclusion criteria (14 listed)
- pre-existing:
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 |
|---|---|---|
| Forearm plethysmographyDose response study | Procedure or surgery | Apelin infusion - forearm |
| Haemodynamic studiesAlso: Innocor, Bioimpedance, EchocardiographyDose response study | Procedure or surgery | Systemic Apelin infusion |
Primary outcome
Percentage change in forearm blood flow in the infused arm. Forearm blood flow ratio in each arm, blood pressure and heart rate will also be reported.
Time frame: 12 months
Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate.
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 25 Jun 2015.
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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.
Dr. Joseph Cheriyan, MD principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm plethysmography and Haemodynamic studies in people with COPD and Pulmonary Hypertension, run by Cambridge University Hospitals NHS Foundation Trust 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 7 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 25 Jun 2015. 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?
Percentage change in forearm blood flow in the infused arm. Forearm blood flow ratio in each arm, blood pressure and heart rate will also be reported. (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?
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 25 Jun 2015.