Trial · NCT05564637
A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
NCT05564637, Phase 2, Completed, Mayo Clinic; results first posted 2025-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension. Trials, record NCT05564637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05564637
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
- NCT number
- NCT05564637
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Pulmonary Arterial Hypertension, Interstitial Lung Disease, Healthy Adults
- Interventions
- Treprostinil, Right Heart Catheterization (RHC) while exercising, Optional Muscle Biopsy
- First posted
- 2022-10-03
- Last updated
- 2025-12-03
- Results first posted
- 2025-12-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cardiac Output Reserve (Qc) | Baseline, approximately 35 minutes | Cardiac output reserve (Qc) is the difference between the heart's maximum output during exercise and its resting output. This was measured using the direct Fick method (L/min). |
| Secondary | Ventilatory Efficiency (VE/VCO2) | Baseline, approximately 35 minutes | Ventilatory efficiency was assessed as a ratio between the ventilation (VE) and carbon dioxide production (VCO2) measured during the RHC procedure. VE/VCO2 evaluates how efficiently a person breathes during exercise. |
| Secondary | New York Heart Association (NYHA) Functional Class | Baseline, 3-months | Participants severity of heart failure symptoms was classified according to the NHYA functional class (I-IV). Lower classifications indicate lower severity of heart failure symptoms. |
| Secondary | Resting Pulmonary Vascular Resistance | Baseline; after 30 minutes of rest | Resting pulmonary vascular resistance was measured in Wood units (mm Hg/L/min) during the RHC procedure. Resting pulmonary vascular resistance is the resistance against blood flow from the pulmonary veins to the left atrium of the heart. |
| Secondary | Exercise Pulmonary Vascular Resistance | Baseline; approximately 35 minutes | Exercise pulmonary vascular resistance was measured in Wood units (mm Hg/L/min) during the RHC procedure. |
| Secondary | Resting Pulmonary Artery Pressure | Baseline; after 30 minutes of rest | Resting pulmonary artery pressure (mmHg) was measured during the RHC procedure. Pulmonary artery pressure is the pressure within the pulmonary arteries, which transport deoxygenated blood from the right side of the heart to the lungs for oxygenation. |
| Secondary | Exercise Pulmonary Artery Pressure | Baseline; approximately 35 minutes | Exercise Pulmonary artery pressure (mmHg) was measured during the RHC procedure. Pulmonary artery pressure is the pressure within the pulmonary arteries, which transport deoxygenated blood from the right side of the heart to the lungs for oxygenation. |
| Secondary | Resting Right Atrial Pressure | Baseline; after 30 minutes of rest | Resting right atrial pressure (mmHg) was measured during the RHC procedure. Right atrial pressure is a measurement that reflects the amount of blood returning to the heart and the heart's ability to pump blood into the arterial system. |
| Secondary | Exercise Right Atrial Pressure | Baseline; approximately 35 minutes | Exercise right atrial pressure (mmHg) was measured during the RHC procedure. Right atrial pressure is a measurement that reflects the amount of blood returning to the heart and the heart's ability to pump blood into the arterial system. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cardiac Output Reserve (Qc) | Baseline, approximately 35 minutes | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Liters/Min | MEAN |
| SECONDARY | Ventilatory Efficiency (VE/VCO2) | Baseline, approximately 35 minutes | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Ratio | MEAN |
| SECONDARY | New York Heart Association (NYHA) Functional Class | Baseline, 3-months | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Resting Pulmonary Vascular Resistance | Baseline; after 30 minutes of rest | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | mm Hg/L/min | MEAN |
| SECONDARY | Exercise Pulmonary Vascular Resistance | Baseline; approximately 35 minutes | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | mm Hg/L/min | MEAN |
| SECONDARY | Resting Pulmonary Artery Pressure | Baseline; after 30 minutes of rest | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | mmHg | MEAN |
| SECONDARY | Exercise Pulmonary Artery Pressure | Baseline; approximately 35 minutes | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | mmHg | MEAN |
| SECONDARY | Resting Right Atrial Pressure | Baseline; after 30 minutes of rest | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | mmHg | MEAN |
| SECONDARY | Exercise Right Atrial Pressure | Baseline; approximately 35 minutes | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cardiac Output Reserve (Qc) | PAH-ILD Patients | Baseline | 3.3 | Standard Deviation 2.1 | Liters/Min |
| Cardiac Output Reserve (Qc) | PAH-ILD Patients | Approximately 35 minutes | 3.8 | Standard Deviation 1.8 | Liters/Min |
| Ventilatory Efficiency (VE/VCO2) | PAH-ILD Patients | Baseline | 50.4 | Standard Deviation 10.6 | Ratio |
| Ventilatory Efficiency (VE/VCO2) | PAH-ILD Patients | Approximately 35 Minutes | 51.2 | Standard Deviation 11.2 | Ratio |
| New York Heart Association (NYHA) Functional Class | PAH-ILD Patients | NYHA I | 1 | Participants | |
| New York Heart Association (NYHA) Functional Class | PAH-ILD Patients | NYHA II | 9 | Participants | |
| New York Heart Association (NYHA) Functional Class | PAH-ILD Patients | NYHA III | 6 | Participants | |
| New York Heart Association (NYHA) Functional Class | PAH-ILD Patients | NYHA IV | 6 | Participants | |
| Resting Pulmonary Vascular Resistance | PAH-ILD Patients | Baseline | 5.4 | Standard Deviation 2.1 | mm Hg/L/min |
| Resting Pulmonary Vascular Resistance | PAH-ILD Patients | After 30 minutes of Rest | 3.1 | Standard Deviation 1.4 | mm Hg/L/min |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Healthy Volunteers | 1 | |
| Overall Study | STARTED | PAH-ILD Patients | 23 | |
| Overall Study | COMPLETED | Healthy Volunteers | 1 | |
| Overall Study | COMPLETED | PAH-ILD Patients | 22 | |
| Overall Study | NOT COMPLETED | Healthy Volunteers | 0 | |
| Overall Study | NOT COMPLETED | PAH-ILD Patients | 1 |
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Healthy Volunteers | 0 | 1 |
| Total, all-cause mortality | PAH-ILD Patients | 0 | 23 |
| Total, other adverse events | Healthy Volunteers | 0 | 1 |
| Total, other adverse events | PAH-ILD Patients | 0 | 23 |
| Total, serious adverse events | Healthy Volunteers | 0 | 1 |
| Total, serious adverse events | PAH-ILD Patients | 0 | 23 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Healthy Volunteers vs PAH-ILD Patients: deaths from any cause | Trial comparisons |
| Healthy Volunteers vs PAH-ILD Patients: serious adverse events | 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/NCT05564637
GET https://conductscience.org/api/trials/v1/NCT05564637/registered