Pulmonary HypertensionNCT02858791
MIF- Thyroxine Interactions in the Pathogenesis of Pulmonary Arterial Hypertension
An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Northwell Health at 1 site in United States.
Trial summary
The investigators will investigate the interrelationship of macrophage migration inhibitory factor (MIF) and free T4 in patients with PAH. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Interstitial Lung Disease
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 21 Dec 2017
- Phase
- Observational
- 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
Study population: Subjects are either a healthy volunteer, or patietns who have confirmed pulmonary hypertension and interstitial lung disease
Who may be able to join
- Subject must be at least 18 years of age and have confirmed pulmonary hypertension (PH) and interstitial lung disease (ILD).
- ILD was identified on high resolution computed tomography along with a total lung capacity (TLC) <70% of predicted value on pulmonary function tests (PFTs) with no evidence of pulmonary hypertension on echocardiogram.
- PAH group patients were defined as patients with a mean pulmonary artery pressure >25 mmHg at rest and a wedge pressure of <15 mmHg (millimeters of mercury), measured by right heart catheterization (WHO group I PAH).
- PH+ILD group, subjects with evidence of ILD on high resolution CT Scan and mean pulmonary artery pressure >25 mmHg on right heart catheterization.
- Patient with evidence of Chronic thromboembolic disease on CT angiogram and mean pulmonary artery pressure >25mmHg on right heart catheterization. (WHO group IV)
- Patient with Pulmonary Hypertension due to other conditions, such as Sarcoidosis, Gauchers disease, Hemolytic Anemia and Myeloproliferative disorders.
- Normal control group: Subjects without cardiopulmonary disease, with a normal PFT and ECG.
Who cannot join
- Failure to obtain informed consent;
- Pregnancy
- Subjects with cardiopulmonary disease other than PH and ILD;
- Unexplained abnormal PFT, ECG, Routine blood/chemistries test
- History or existing other sever organ/system diseases
- Defined Acute pulmonary embolism
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will investigate the interrelationship of macrophage migration inhibitory factor (MIF) and free T4 in patients with PAH.
Read the detailed description
The investigators will test our hypothesis and accomplish our objectives by pursuing three Specific Aims:
To investigate the interrelationship between macrophage migration inhibitory factor (MIF) and free T4 in patients with PAH with a working hypothesis that an increased release of MIF into the pulmonary vasculature during cardiopulmonary exercise changes the normal balance between plasma MIF and T4.
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Subjects are made up of healthy adults Interventions: Venous blood drawn before and after cardiopulmonary exercise test Will have a resting 12 lead EKG Undergo pulmonary function test | |
| Affected | Subjects have Pulmonary Hypertension Subjects have Pulmonary hypertension with Interstitial lung disease Subjects have Interstitial lung disease Interventions: Venous blood drawn before and after cardiopulmonary exercise test Will have a resting 12 lead EKG Undergo pulmonary function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the MIF-T4 relationship in patients before/after a standardized exercise challenge
Assess levels of the proinflammatory cytokine macrophage migration inhibitory factor (MIF) before/after standard exercise challenge
Measured: up to 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startFeb 2013
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arunabh Talwar, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858791
- Sponsor's protocol ID
- 13-003A
- Status last verified
- Jan 2018
- First submitted
- 14 Jun 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIF- Thyroxine Interactions in the Pathogenesis of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02858791
- Acronym / sponsor ID
- 13-003A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 8 Aug 2016 (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 will investigate the interrelationship of macrophage migration inhibitory factor (MIF) and free T4 in patients with PAH.
Detailed description
The investigators will test our hypothesis and accomplish our objectives by pursuing three Specific Aims:
To investigate the interrelationship between macrophage migration inhibitory factor (MIF) and free T4 in patients with PAH with a working hypothesis that an increased release of MIF into the pulmonary vasculature during cardiopulmonary exercise changes the normal balance between plasma MIF and T4.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Subjects are made up of healthy adults Interventions: Venous blood drawn before and after cardiopulmonary exercise test Will have a resting 12 lead EKG Undergo pulmonary function test |
| Affected | – | –Subjects have Pulmonary Hypertension Subjects have Pulmonary hypertension with Interstitial lung disease Subjects have Interstitial lung disease Interventions: Venous blood drawn before and after cardiopulmonary exercise test Will have a resting 12 lead EKG Undergo pulmonary function test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are either a healthy volunteer, or patietns who have confirmed pulmonary hypertension and interstitial lung disease
Key inclusion criteria (7 listed)
- Subject must be at least 18 years of age and have confirmed pulmonary hypertension (PH) and interstitial lung disease (ILD).
- ILD was identified on high resolution computed tomography along with a total lung capacity (TLC) <70% of predicted value on pulmonary function tests (PFTs) with no evidence of pulmonary hypertension on echocardiogram.
- PAH group patients were defined as patients with a mean pulmonary artery pressure >25 mmHg at rest and a wedge pressure of <15 mmHg (millimeters of mercury), measured by right heart catheterization (WHO group I PAH).
- PH+ILD group, subjects with evidence of ILD on high resolution CT Scan and mean pulmonary artery pressure >25 mmHg on right heart catheterization.
- Patient with evidence of Chronic thromboembolic disease on CT angiogram and mean pulmonary artery pressure >25mmHg on right heart catheterization. (WHO group IV)
Key exclusion criteria (7 listed)
- Failure to obtain informed consent;
- Pregnancy
- Subjects with cardiopulmonary disease other than PH and ILD;
- Unexplained abnormal PFT, ECG, Routine blood/chemistries test
- History or existing other sever organ/system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To examine the MIF-T4 relationship in patients before/after a standardized exercise challenge
Time frame: up to 30 mins
Assess levels of the proinflammatory cytokine macrophage migration inhibitory factor (MIF) before/after standard exercise challenge
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 Jan 2018.
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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?
An observational study of Pulmonary Hypertension and 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 7 inclusion and 7 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 Jan 2018. 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?
To examine the MIF-T4 relationship in patients before/after a standardized exercise challenge (time frame: up to 30 mins). 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 9 Jan 2018.