Pulmonary HypertensionNCT01961232
Trans-pulmonary Biomarkers in Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pulmonary Vascular Clinic
Who may be able to join
- Age ≥ 18 years old
- Undergoing RHC for PH evaluation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Examination of Trans-pulmonary Biomarkers in Pulmonary Hypertension: a Potential Step Towards Personalized Therapy
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.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, biomarker, cardiac, circulation, heart disease, lung disease
- Medical subject headings
- Hypertension, Pulmonary, Heart Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension
Measured: At baseline
Secondary outcomes (2)
Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR)
Measured: At baseline
Vasodilator-induced changes in Pulmonary Hypertension biomarkers
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Ken Monahan, Vanderbilt University
- Investigators
- Ken Monahan, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961232
- Sponsor's protocol ID
- IRB090650
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2013
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24015334
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Trans-pulmonary Biomarkers in Pulmonary Hypertension: a Potential Step Towards Personalized Therapy
- ClinicalTrials.gov ID
- NCT01961232
- Acronym / sponsor ID
- IRB090650
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, biomarker, cardiac, circulation, heart disease, lung disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Aug 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonary Vascular Clinic
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- Undergoing RHC for PH evaluation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension
Time frame: At baseline
2 secondary outcomes
Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR)
Time frame: At baseline
Vasodilator-induced changes in Pulmonary Hypertension biomarkers
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 24015334Monahan 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.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Monahan, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01961232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.