MIF- Thyroxine Interactions in the Pathogenesis of Pulmonary Arterial Hypertension

The investigators will investigate the interrelationship of macrophage migration inhibitory factor (MIF) and free T4 in patients with PAH.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension; Interstitial Lung Disease

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 Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 21, 2017
• Study Completion (Actual): December 21, 2017

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Hypertension; Lung Diseases; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Lung Diseases, Interstitial
• Other Study ID Numbers: 13-003A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No