This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Trans-pulmonary Biomarkers in Pulmonary Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Kenneth Monahan, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01961232
First received: September 19, 2013
Last updated: January 27, 2017
Last verified: January 2017
  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.

Condition
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examination of Trans-pulmonary Biomarkers in Pulmonary Hypertension: a Potential Step Towards Personalized Therapy

Resource links provided by NLM:


Further study details as provided by Kenneth Monahan, Vanderbilt University:

Primary Outcome Measures:
  • Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension [ Time Frame: At baseline ]

Secondary Outcome Measures:
  • Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR) [ Time Frame: At baseline ]
  • Vasodilator-induced changes in Pulmonary Hypertension biomarkers [ Time Frame: At baseline ]

Other Outcome Measures:
  • Differences between Pulmonary Hypertension-related biomarkers in pulmonary circulation and peripheral-venous circulation [ Time Frame: At baseline ]

Biospecimen Retention:   Samples With DNA
whole blood

Estimated Enrollment: 100
Actual Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pulmonary Vascular Clinic
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961232

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Gilead Sciences
Investigators
Principal Investigator: Ken Monahan, MD Vanderbilt University Medical Center
  More Information

Publications:
Responsible Party: Kenneth Monahan, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01961232     History of Changes
Other Study ID Numbers: IRB090650
Study First Received: September 19, 2013
Last Updated: January 27, 2017

Keywords provided by Kenneth Monahan, Vanderbilt University:
Pulmonary Hypertension
biomarker
cardiac
circulation
heart disease
lung disease

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 23, 2017