Trans-pulmonary Biomarkers in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01961232
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : January 5, 2018
Gilead Sciences
Information provided by (Responsible Party):
Kenneth Monahan, Vanderbilt University

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
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 Type : Observational
Estimated 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 : August 2013
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension [ Time Frame: At baseline ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Differences between Pulmonary Hypertension-related biomarkers in pulmonary circulation and peripheral-venous circulation [ Time Frame: At baseline ]

Biospecimen Retention:   Samples With DNA
whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pulmonary Vascular Clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01961232

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Gilead Sciences
Principal Investigator: Ken Monahan, MD Vanderbilt University Medical Center

Responsible Party: Kenneth Monahan, Assistant Professor, Vanderbilt University Identifier: NCT01961232     History of Changes
Other Study ID Numbers: IRB090650
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by Kenneth Monahan, Vanderbilt University:
Pulmonary Hypertension
heart disease
lung disease

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases