Trans-pulmonary Biomarkers in Pulmonary Hypertension

NCT ID: NCT01961232

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Hypertension & WHO group I

Participants with Pulmonary Hypertension with a WHO classification group I and are scheduled to have a right heart catheterization.

No interventions assigned to this group

Pulmonary Hypertension & WHO group II

Participants with Pulmonary Hypertension with a WHO classification group II and are scheduled to have a right heart catheterization.

No interventions assigned to this group

Without Pulmonary Hypertension

Participants without Pulmonary Hypertension

No interventions assigned to this group

Connective Tissue Disease

Participants without PH, but with connective tissue disease

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Ken Monahan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ken Monahan, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24015334 (View on PubMed)

Other Identifiers

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IRB090650

Identifier Type: -

Identifier Source: org_study_id

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