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NCT Number: NCT01961232

Trans-pulmonary Biomarkers in Pulmonary Hypertension

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension

    Time frame: At baseline

Secondary outcomes

  1. Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR)

    Time frame: At baseline

  2. Vasodilator-induced changes in Pulmonary Hypertension biomarkers

    Time frame: At baseline

Other outcomes

  1. Differences between Pulmonary Hypertension-related biomarkers in pulmonary circulation and peripheral-venous circulation

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2027
First posted
Oct 11, 2013
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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