Pulmonary Arterial HypertensionBiomarkersNCT00566423
Biomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH)
A study testing Blood draw in people with Pulmonary Arterial Hypertension, run by Northwell Health at 1 site in United States.
Trial summary
The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post exercise. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of PAH, based on currently accepted gold standard for Right Heart Catheterization.
- Patients with mean artery pressure of greater that 25 mm Hg at rest or 30mm Hg during exercise with pulmonary capillary wedge pressure less than 18mm Hg on right heart catheterization.
Who cannot join
- Significant left heart disease or renal insufficiency (serum creatinine > 1.5 mg%).
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore-Long Island Health System
New Hyde Park, New York, 11040
About this study
Official title: Biomarkers in the Diagnosis and Assessment of PAH
The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post exercise.
Read the detailed description
As above
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Blood draw
- Keywords
- PAH, Biomarkers, MIF, BNP, 6 Minute Walk (6MW)
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Venous and Arterial Blood draw samples; 6 Minute Walk test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with Pulmonary Arterial Hypertension Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the correlation of plasma/arterial BNP and MIF levels pre/post with the 6 Minute walk test distance and echocardiographic parameters as surrogate markers of severity of PAH.
Measured: 2 year
Secondary outcomes (1)
To determine if changes in plasma/arterial MIF levels pre/post 6MW test are due to MIF released from the lungs
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Investigators
- Arunabh Talwar, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566423
- Sponsor's protocol ID
- 07-030
- Other IDs
- NS-LIJHS IRB # 07-030
- Acronym
- Biomarkers
- Status last verified
- Jun 2011
- First submitted
- 29 Nov 2007
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in the Diagnosis and Assessment of PAH
- ClinicalTrials.gov ID
- NCT00566423
- Acronym / sponsor ID
- Biomarkers / 07-030
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH, Biomarkers, MIF, BNP, 6 Minute Walk (6MW)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Dec 2007 (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 hypothesize that baseline plasma brain natriuretic peptide (BNP) and migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post exercise.
Detailed description
As above
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Blood drawPatients with Pulmonary Arterial Hypertension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of PAH, based on currently accepted gold standard for Right Heart Catheterization.
- Patients with mean artery pressure of greater that 25 mm Hg at rest or 30mm Hg during exercise with pulmonary capillary wedge pressure less than 18mm Hg on right heart catheterization.
Key exclusion criteria (1 listed)
- Significant left heart disease or renal insufficiency (serum creatinine > 1.5 mg%).
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 |
|---|---|---|
| Blood drawVenous and Arterial Blood draw samples; 6 Minute Walk test | Other | 1 |
Primary outcome
Assess the correlation of plasma/arterial BNP and MIF levels pre/post with the 6 Minute walk test distance and echocardiographic parameters as surrogate markers of severity of PAH.
Time frame: 2 year
1 secondary outcome
To determine if changes in plasma/arterial MIF levels pre/post 6MW test are due to MIF released from the lungs
Time frame: 2 year
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 23 Jun 2011.
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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.
Arunabh Talwar, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw in people with Pulmonary Arterial Hypertension, run by Northwell Health at 1 site in United States.
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 1 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 23 Jun 2011. 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 States. 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?
Assess the correlation of plasma/arterial BNP and MIF levels pre/post with the 6 Minute walk test distance and echocardiographic parameters as surrogate markers of severity of PAH. (time frame: 2 year). 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 23 Jun 2011.