Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-21 @ 5:49 AM
Study NCT ID:
NCT01961232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2013-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans-pulmonary Biomarkers in Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-08', 'studyFirstSubmitDate': '2013-09-19', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differences between Pulmonary Hypertension-related biomarkers in pulmonary circulation and peripheral-venous circulation', 'timeFrame': 'At baseline'}], 'primaryOutcomes': [{'measure': 'Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension', 'timeFrame': 'At baseline'}], 'secondaryOutcomes': [{'measure': 'Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR)', 'timeFrame': 'At baseline'}, {'measure': 'Vasodilator-induced changes in Pulmonary Hypertension biomarkers', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'biomarker', 'cardiac', 'circulation', 'heart disease', 'lung disease'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '24015334', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pulmonary Vascular Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Undergoing RHC for PH evaluation\n\nExclusion Criteria:\n\n* Anemia defined as Hgb \\< 10 g/dL and HCT \\< 30\n* Pregnancy at the time of RHC (as assessed by urine or serum pregnancy test on the day of the procedure)\n* Left ventricular ejection fraction ≤ 40%\n* Atrial fibrillation at the time of RHC (as defined by telemetry monitoring or EKG on the day of the procedure)\n* IPF, CTEPH, COPD/OSA as the dominant etiology of PH\n* Patient is currently taking PH medication or long-acting nitrates at the time of their RHC.'}, 'identificationModule': {'nctId': 'NCT01961232', 'briefTitle': 'Trans-pulmonary Biomarkers in Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Examination of Trans-pulmonary Biomarkers in Pulmonary Hypertension: a Potential Step Towards Personalized Therapy', 'orgStudyIdInfo': {'id': 'IRB090650'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Hypertension & WHO group I', 'description': 'Participants with Pulmonary Hypertension with a WHO classification group I and are scheduled to have a right heart catheterization.'}, {'label': 'Pulmonary Hypertension & WHO group II', 'description': 'Participants with Pulmonary Hypertension with a WHO classification group II and are scheduled to have a right heart catheterization.'}, {'label': 'Without Pulmonary Hypertension', 'description': 'Participants without Pulmonary Hypertension'}, {'label': 'Connective Tissue Disease', 'description': 'Participants without PH, but with connective tissue disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Ken Monahan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ken Monahan', 'investigatorAffiliation': 'Vanderbilt University'}}}}