Pulmonary HypertensionPhase 4NCT04231084
Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide
A Phase 4 study testing Vasodilator testing (Inhaled Nitric Oxide) and Vasodilator testing (Inhaled Epoprostenol) in people with Pulmonary Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Vasodilator testing (Inhaled Nitric Oxide) and Vasodilator testing (Inhaled Epoprostenol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 1 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- mPAP ≥ 21mmHg, PAWP ≤ 25mmHg, and PVR ≥3 WU
- Classified as WHO group I-III pulmonary hypertension
Who cannot join
- WHO group IV and V pulmonary hypertension
- Patients who are on baseline pulmonary vasodilator medications
- Severe aortic or mitral valve disease
- Patients who are pregnant
- Left ventricular ejection fraction of <35%
- Patients who are hospitalized as inpatients at the time of RHC
- Patients with systolic blood pressure <90mmHg or mean arterial pressure of < 60mmHg
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Acute Hemodynamic Comparison of Inhaled Nitric Oxide and Inhaled Epoprostenol in Pulmonary Hypertension
The overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype.
- Conditions
- Pulmonary Hypertension
- Being tested
- Vasodilator testing (Inhaled Nitric Oxide), Vasodilator testing (Inhaled Epoprostenol)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasodilator testing (Inhaled Nitric Oxide)Drug
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
Vasodilator testing (Inhaled Epoprostenol)Drug
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide | Active comparator | Vasodilator testing will be performed with inhaled nitric oxide Receives: Drug: Vasodilator testing (Inhaled Nitric Oxide) |
| Inhaled Epoprostenol | Experimental | Vasodilator testing will be performed with inhaled epoprostenol Receives: Drug: Vasodilator testing (Inhaled Epoprostenol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean pulmonary artery pressure
The primary outcome will be change in mean pulmonary artery pressure (mmHg) from baseline to after 5-minutes of inhaled vasodilator.
Measured: Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start15 Jan 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Waxman MD PhD, Brigham and Women's Hospital
- Investigators
- Aaron B Waxman, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231084
- Sponsor's protocol ID
- 2019P003491
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2020
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic Comparison of Inhaled Nitric Oxide and Inhaled Epoprostenol in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04231084
- Acronym / sponsor ID
- 2019P003491
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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 overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide | Active comparator | Drug: Vasodilator testing (Inhaled Nitric Oxide)Vasodilator testing will be performed with inhaled nitric oxide |
| Inhaled Epoprostenol | Experimental | Drug: Vasodilator testing (Inhaled Epoprostenol)Vasodilator testing will be performed with inhaled epoprostenol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mPAP ≥ 21mmHg, PAWP ≤ 25mmHg, and PVR ≥3 WU
- Classified as WHO group I-III pulmonary hypertension
Key exclusion criteria (7 listed)
- WHO group IV and V pulmonary hypertension
- Patients who are on baseline pulmonary vasodilator medications
- Severe aortic or mitral valve disease
- Patients who are pregnant
- Left ventricular ejection fraction of <35%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vasodilator testing (Inhaled Nitric Oxide)Right heart catheterization with vasodilator testing with each arms' associated agent will be performed | Drug | Inhaled Nitric Oxide |
| Vasodilator testing (Inhaled Epoprostenol)Right heart catheterization with vasodilator testing with each arms' associated agent will be performed | Drug | Inhaled Epoprostenol |
Primary outcome
Change in mean pulmonary artery pressure
Time frame: Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.
The primary outcome will be change in mean pulmonary artery pressure (mmHg) from baseline to after 5-minutes of inhaled vasodilator.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
Aaron B Waxman, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vasodilator testing (Inhaled Nitric Oxide) and Vasodilator testing (Inhaled Epoprostenol) in people with Pulmonary Hypertension, run by Brigham and Women's Hospital 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 7 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: finished, as of the sponsor's last update on 6 Aug 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in mean pulmonary artery pressure (time frame: Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.