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Pulmonary Hypertension | Trans-pulmonary Biomarkers in Pulmonary Hypertension

Pulmonary Hypertension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pulmonary Hypertension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Without Pulmonary HypertensionParticipants without Pulmonary Hypertension

Connective Tissue DiseaseParticipants without PH, but with connective tissue disease

Study Status

Active, not recruiting

Start Date: August 2013

Completed Date: December 2018

Phase:

Type: Observational

Design:

Primary Outcome: Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension

Secondary Outcome: Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR)

Study sponsors, principal investigator, and references

Principal Investigator: Ken Monahan, MD

Lead Sponsor: Vanderbilt University

Collaborator: Gilead Sciences

More information:https://clinicaltrials.gov/show/NCT01961232

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.

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