Clinical Trials

Trans-pulmonary Biomarkers in Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01961232
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Vanderbilt University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ken Monahan, MD
Principal Investigator Affiliation	Vanderbilt University Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension

Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232