MIF- Thyroxine Interactions in the Pathogenesis of Pulmonary Arterial Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

MIF- Thyroxine Interactions in the Pathogenesis of Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858791
• Other study ID #: 13-003A
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: January 8, 2018
• Start date: February 2013
• Est. completion date: December 21, 2017

Study information

• Verified date: January 2018
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Locations

Country	Name	City	State
United States	Northwell Health	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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