Trans-pulmonary Biomarkers in Pulmonary Hypertension

Sponsor

Vanderbilt University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01961232

Collaborator

Gilead Sciences (Industry)

100

Enrollment

Location

124

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators are testing whether the addition of Pulmonary Hypertension-related biomarkers, measured across the pulmonary circulation, to the standard hemodynamic evaluation for Pulmonary Hypertension will lead to more informed choices of Pulmonary Hypertension therapy and improved patient outcomes.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension

Detailed Description

Eligible participants with known or suspected Pulmonary Hypertension undergoing a clinically indicated right heart catheterization may be enrolled. Clinical data and blood samples will be analyzed.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Examination of Trans-pulmonary Biomarkers in Pulmonary Hypertension: a Potential Step Towards Personalized Therapy

Actual Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Jan 1, 2015

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Pulmonary Hypertension & WHO group I Participants with Pulmonary Hypertension with a WHO classification group I and are scheduled to have a right heart catheterization.
Pulmonary Hypertension & WHO group II Participants with Pulmonary Hypertension with a WHO classification group II and are scheduled to have a right heart catheterization.
Without Pulmonary Hypertension Participants without Pulmonary Hypertension
Connective Tissue Disease Participants without PH, but with connective tissue disease

Outcome Measures

Primary Outcome Measures

Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension [At baseline]

Secondary Outcome Measures

Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR) [At baseline]
Vasodilator-induced changes in Pulmonary Hypertension biomarkers [At baseline]

Other Outcome Measures

Differences between Pulmonary Hypertension-related biomarkers in pulmonary circulation and peripheral-venous circulation [At baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years old
Undergoing RHC for PH evaluation

Exclusion Criteria:

Anemia defined as Hgb < 10 g/dL and HCT < 30
Pregnancy at the time of RHC (as assessed by urine or serum pregnancy test on the day of the procedure)
Left ventricular ejection fraction ≤ 40%
Atrial fibrillation at the time of RHC (as defined by telemetry monitoring or EKG on the day of the procedure)
IPF, CTEPH, COPD/OSA as the dominant etiology of PH
Patient is currently taking PH medication or long-acting nitrates at the time of their RHC.