This trial is active, not recruiting.

Condition pulmonary hypertension
Sponsor Vanderbilt University
Collaborator Gilead Sciences
Start date August 2013
End date December 2016
Trial size 100 participants
Trial identifier NCT01961232, IRB090650


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Participants with Pulmonary Hypertension with a WHO classification group I and are scheduled to have a right heart catheterization.
Participants with Pulmonary Hypertension with a WHO classification group II and are scheduled to have a right heart catheterization.
Participants without Pulmonary Hypertension
Participants without PH, but with connective tissue disease

Primary Outcomes

Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension
time frame: At baseline

Secondary Outcomes

Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR)
time frame: At baseline
Vasodilator-induced changes in Pulmonary Hypertension biomarkers
time frame: At baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Examination of Trans-pulmonary Biomarkers in Pulmonary Hypertension: a Potential Step Towards Personalized Therapy
Principal investigator Ken Monahan, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.