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NCT01961232 Clinical Trial

Trans-pulmonary Biomarkers in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01961232
Other study ID # IRB090650
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 2013
Est. completion date June 2026

Study information
Verified date March 2024
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date June 2026
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt University Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Monahan K, Scott TA, Su YR, Lenneman CG, Zhao DX, Robbins IM, Hemnes AR. Reproducibility of intracardiac and transpulmonary biomarkers in the evaluation of pulmonary hypertension. Pulm Circ. 2013 Apr;3(2):345-9. doi: 10.4103/2045-8932.114762. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Differences between Pulmonary Hypertension-related biomarkers in pulmonary circulation and peripheral-venous circulation At baseline
Primary Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension At baseline
Secondary Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR) At baseline
Secondary Vasodilator-induced changes in Pulmonary Hypertension biomarkers At baseline
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