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Trans-pulmonary Biomarkers in Pulmonary Hypertension

Vanderbilt University logo

Vanderbilt University

Status

Active, not recruiting

Conditions

Pulmonary Hypertension

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01961232
IRB090650

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

100 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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