MIF- Thyroxine Interactions in the Pathogenesis of Pulmon... | NCT02858791

Studies
MIF- Thyroxine Interactions in the Pathogenesis of Pulmonary Arterial Hypertension

NCT02858791

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Jan 9, 2018Actual

Enrollment

99Actual

Phase

Not provided

Conditions

Pulmonary Hypertension
Pulmonary Arterial Hypertension
Interstitial Lung Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013Actual

Primary Completion Date

Dec 21, 2017Actual

Completion Date

Dec 21, 2017Actual

First Submitted Date

Jun 14, 2016

First Submission Date that Met QC Criteria

Aug 3, 2016

First Posted Date

Aug 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2018

Last Update Posted Date

Jan 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	up to 30 mins

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects are either a healthy volunteer, or patietns who have confirmed pulmonary hypertension and interstitial lung disease

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Northwell Health		New Hyde Park	New York	11040	United States

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary
D000081029	Pulmonary Arterial Hypertension
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

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Browse Branches

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