Trans-pulmonary Biomarkers in Pulmonary Hypertension

NCT01961232 | Active Not Recruiting

• 1 other identifier: IRB090650
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension; biomarker; cardiac; circulation; heart disease; lung disease

Outcome Measures

Primary Outcomes (1)

• Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension

  At baseline

Secondary Outcomes (2)

• Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR)

  At baseline

• Vasodilator-induced changes in Pulmonary Hypertension biomarkers

  At baseline

Other Outcomes (1)

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

  At baseline

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pulmonary Vascular Clinic

You may qualify if:

• Age ≥ 18 years old
• Undergoing RHC for PH evaluation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related 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.

  PMID: 24015334 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ken Monahan, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: October 11, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)