Trial · NCT03044314
Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension
NCT03044314, Phase 4, Terminated, Duke University; results first posted 2024-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension. Trials, record NCT03044314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03044314
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension
- NCT number
- NCT03044314
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 27 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Pulmonary Hypertension
- Interventions
- Iloprost and nitric oxide administration
- First posted
- 2017-02-07
- Last updated
- 2024-04-02
- Results first posted
- 2024-04-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Invasively Measured Pulmonary Artery Pressures After Challenge With iNO (Inhaled Nitrous Oxide) and Iloprost | Baseline and approximately 30 minutes | |
| Secondary | Percent Change in Systolic Pulmonary Arterial Pressure After Vasodilator Challenge | Baseline and during vasodilator inhalation, approximately 30 minutes | |
| Secondary | Number of Participants Who Respond After Vasodilator Challenge | Baseline and during vasodilator inhalation, approximately 30 minutes | Dichotomize the vasodilator response into responders and nonresponders, based on a 10 mmHg drop in PA pressure and a mean pressure \<40mmHg determined invasively. Receiver operating characteristic (ROC) curves will evaluate the echocardiographic parameters for prediction of vasodilator response. |
| Secondary | Number of Participants With Clinical Response to Vasodilator Challenge by Echo | Baseline, approximately 30 minutes, 3 months, and 12 months | Measure the clinical response to vasodilator challenge during echocardiography, by tracking the changes of echo parameters (such as RVSP) before and after iloprost challenge, as well as through the 3 and 12 month follow-up visits. |
| Secondary | Association of Change in Pressures After Vasodilator Challenge With Clinical Outcomes | 3 months and 12 months | Observe the association of the percent change of echocardiographically estimated pressures after iloprost challenge with mid-term clinical outcomes (all cause mortality and all cause mortality +/- hospitalization). These data will be collected at 3 months and at 12 months. Data from all hospitalizations will be collected though we will make special note of those related to pulmonary hypertension. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Invasively Measured Pulmonary Artery Pressures After Challenge With iNO (Inhaled Nitrous Oxide) and Iloprost | Baseline and approximately 30 minutes | Participants who completed the study. Each participant was analyzed after challenge with iNO and after challenge with iloprost. | percent change | MEAN |
| SECONDARY | Percent Change in Systolic Pulmonary Arterial Pressure After Vasodilator Challenge | Baseline and during vasodilator inhalation, approximately 30 minutes | Participants who completed the study. Two patients refused to undergo echocardiography and repeat inhalation of iloprost. | percentage of change | MEAN |
| SECONDARY | Number of Participants Who Respond After Vasodilator Challenge | Baseline and during vasodilator inhalation, approximately 30 minutes | Participants who completed the study. Each participant was analyzed after challenge with iNO and after challenge with iloprost. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response to Vasodilator Challenge by Echo | Baseline, approximately 30 minutes, 3 months, and 12 months | Participants who completed the study. Two patients refused to undergo echocardiography and repeat inhalation of iloprost. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Association of Change in Pressures After Vasodilator Challenge With Clinical Outcomes | 3 months and 12 months | 0 participants had a change of echocardiographically estimated pressures, as indicated in outcome #4 |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Invasively Measured Pulmonary Artery Pressures After Challenge With iNO (Inhaled Nitrous Oxide) and Iloprost | Inhaled Nitric Oxide | 10.7 | Standard Deviation 7.1 | percent change | |
| Change in Invasively Measured Pulmonary Artery Pressures After Challenge With iNO (Inhaled Nitrous Oxide) and Iloprost | Iloprost | 13.3 | Standard Deviation 12.5 | percent change | |
| Percent Change in Systolic Pulmonary Arterial Pressure After Vasodilator Challenge | Inhaled Nitric Oxide and Iloprost Administration | 0 | Standard Deviation 0 | percentage of change | |
| Number of Participants Who Respond After Vasodilator Challenge | Inhaled Nitric Oxide | 1 | Participants | ||
| Number of Participants Who Respond After Vasodilator Challenge | Iloprost | 4 | Participants | ||
| Number of Participants With Clinical Response to Vasodilator Challenge by Echo | Inhaled Nitric Oxide and Iloprost Administration | Baseline | 0 | Participants | |
| Number of Participants With Clinical Response to Vasodilator Challenge by Echo | Inhaled Nitric Oxide and Iloprost Administration | 30 minutes | 0 | Participants | |
| Number of Participants With Clinical Response to Vasodilator Challenge by Echo | Inhaled Nitric Oxide and Iloprost Administration | 3 months | 0 | Participants | |
| Number of Participants With Clinical Response to Vasodilator Challenge by Echo | Inhaled Nitric Oxide and Iloprost Administration | 12 months | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nitric Oxide and Iloprost Administration | 27 | |
| Overall Study | COMPLETED | Nitric Oxide and Iloprost Administration | 23 | |
| Overall Study | NOT COMPLETED | Nitric Oxide and Iloprost Administration | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iloprost and Nitric Oxide Administration | 0 | 27 |
| Total, other adverse events | Iloprost and Nitric Oxide Administration | 0 | 27 |
| Total, serious adverse events | Iloprost and Nitric Oxide Administration | 0 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Inhaled Nitric Oxide vs Iloprost: Number of Participants Who Respond After Vasodilator Challenge |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03044314
GET https://conductscience.org/api/trials/v1/NCT03044314/registered