An Early Phase 1 interventional study of Treprostinil and Standard of Care in Pulmonary Hypertension, sponsored by Valley Health System. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Valley Health System · Early Phase 1, Interventional, and Treatment
Among 38 studies testing treprostinil in Hypertension, Pulmonary — 4 open to participants now, 4 under way, 1 of them phase 3. treprostinil · Hypertension, Pulmonary.
Among the 38 studies testing treprostinil in Hypertension, Pulmonary, this one is the 19th largest by planned enrollment of the 37 interventional ones, is one of 2 that started in 2026, is one of 5 in phase 1, and was the 38th registered.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 32 is close to the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →4 of the 38 studies testing treprostinil in Hypertension, Pulmonary are open now, in 12 countries. Each count lists the studies.
treprostinil: first FDA approval 2002 (REMODULIN), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 164 Hypertension, Pulmonary studies recruiting now, 100 (61%) set no upper age limit and 26 (16%) stop at 75 or younger; 39 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →38 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 2 started in 2026.
Median enrollment 32 across the 37 interventional studies. Of the 29 that completed or were terminated, 19 (66%) have results posted.
28 of 38 have an industry lead sponsor. The 10 most frequent:
Valley Health System is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Valley Health System has 1 study filed under Hypertension, Pulmonary — fewer than ten, so there is no comparison to draw.
1 of the studies testing treprostinil in Hypertension, Pulmonary that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07116681University of California, San DiegoEffects of Inhaled Treprostinil on Exercise Performance in Exercise Induced Pulmonary Hypertension | 2027-07-01 |
Among the 38 studies testing treprostinil in Hypertension, Pulmonary, from their registry updates:
Nothing recorded among them since 2026-09-25.
This prospective open-label matched-control pilot study evaluates whether inhaled treprostinil improves exercise pulmonary vascular resistance and functional outcomes in adults with interstitial lung disease or connective tissue disease and exercise-induced pulmonary hypertension. Participants will receive inhaled treprostinil plus standard care or standard care alone and will be followed for 6 months, with an optional extension to 12 months.
1.1 Purpose/Specific Aims This pilot study aims to determine whether early treatment of exercise-induced pulmonary hypertension with inhaled Treprostinil can improve pulmonary vascular hemodynamics, preserve cardiopulmonary reserve, and delay progression to overt resting pulmonary hypertension in patients with interstitial lung disease (ILD) or connective tissue disease (CTD).
A. Objectives
Primary Objective:
Secondary Objectives:
Hypotheses / Research Question(s) Treatment with inhaled treprostinil in patients with PH-ILD or PH-CTD with exercise-induced pulmonary hypertension will result in improvement in pulmonary vascular physiology and clinical outcomes. Specifically, inhaled treprostinil administered over 6 months is hypothesized to reduce exercise pulmonary vascular resistance (PVR), improve exercise hemodynamic parameters including mPAP/CO slope, right ventricular stroke work index, and pulmonary arterial compliance, enhance functional capacity as measured by 6-minute walk distance, and improve exercise tolerance and dyspnea as assessed by BORG scores. Inhaled treprostinil is further hypothesized to be safe and well tolerated in this population and may reduce progression to resting pulmonary hypertension, with sustained hemodynamic and functional benefits observed at 12 months among patients continuing therapy
Research Procedures Screening: Resting RHC on all ILD and CTD patients to exclude resting PH.
Baseline: Exercise RHC + iCPET to identify exercise PH and then select eligible patients. Once a matched pair is identified, one participant will be assigned to receive inhaled treprostinil and the other will receive standard of care. Assignment within each matched pair will be determined using a simple allocation method (such as alternating assignment) to reduce bias.
Treatment Period: 6 months with monthly visits (or more if needed) with 6MWT, BNP, safety assessments.
Primary Endpoint: Month 6 exercise RHC + iCPET, functional and quality of life assessments.
Go/No-Go Decision: Extend to 12 months if ≥ 1.0 WU reduction in peak VR, acceptable safety, ≥ 70% completion rate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Resting RHC:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive inhaled treprostinil (Tyvaso) in addition to standard disease-specific care.
Drug: Treprostinil
Participants receive standard disease-specific care without inhaled treprostinil
Other: Standard of Care
Description: * Initial dose 18 mcg four times daily * Titrated to 54-72 mcg four times daily as tolerated Standard disease-specific therapy continues
Standard management of ILD/CTD without treprostinil.
Change in Exercise Pulmonary Vascular Resistance (PVR)
Change in exercise pulmonary vascular resistance (PVR) from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The primary analysis will compare the change in exercise PVR between the inhaled treprostinil and standard-of-care groups
Time frame: Baseline to Month 6
Incidence of Adverse Events and Treatment Discontinuations
Incidence of adverse events, serious adverse events, treatment discontinuations, and medication tolerability during treatment with inhaled treprostinil.
Time frame: Through Month 6
Progression to Resting Pulmonary Hypertension
Proportion of participants who develop resting pulmonary hypertension at Month 12, defined as resting mean pulmonary artery pressure (mPAP) \>20 mmHg and pulmonary vascular resistance (PVR) \>2 Wood Units measured by right heart catheterization
Time frame: Month 12
Change in Exercise Pulmonary Vascular Resistance (PVR) at Month 12
Change in exercise pulmonary vascular resistance (PVR), measured in Wood Units (WU), from baseline to Month 12 among participants continuing in the extension phase.
Time frame: Month 12
Change in Right Ventricular Stroke Work Index (RVSWI) at Month 6
Change in right ventricular stroke work index (RVSWI) from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The primary analysis will compare the change in RVSWI between the inhaled treprostinil and standard-of-care groups.
Time frame: Baseline to Month 6
Change in Pulmonary Arterial Compliance at Month 6
Change in pulmonary arterial compliance from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The primary analysis will compare the change in pulmonary arterial compliance between the inhaled treprostinil and standard-of-care groups.
Time frame: Baseline to Month 6
Change in 6-Minute Walk Distance at Month 6
Change in 6-minute walk distance (meters) from baseline to Month 6. The analysis will compare the change between the inhaled treprostinil and standard-of-care groups.
Time frame: Baseline to Month 6
Change in Dyspnea Severity (Borg Scale) at Month 6
Change from baseline to Month 6 in dyspnea severity measured using the Borg Category Ratio (CR10) Dyspnea Scale. Scores range from 0 to 10, where 0 indicates no breathlessness and 10 indicates maximal breathlessness. Higher scores indicate worse dyspnea.
Time frame: Baseline to Month 6
Change in 6-Minute Walk Distance at Month 12
Change in 6-minute walk distance, measured in meters, from baseline to Month 12 among participants continuing in the extension phase.
Time frame: Month 12
Change in Mean Pulmonary Artery Pressure/Cardiac Output (mPAP/CO) Slope at Month 6
Change in mPAP/CO slope from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The analysis will compare the change between the inhaled treprostinil and standard-of-care groups.
Time frame: Baseline to Month 6
Change in Dyspnea Severity (Borg Category Ratio [CR10] Dyspnea Scale) at Month 12
Change from baseline to Month 12 in dyspnea severity measured using the Borg Category Ratio (CR10) Dyspnea Scale. Scores range from 0 to 10, with higher scores indicating worse dyspnea.
Time frame: Month 12
Plan to share: No — Individual participant data will not be shared. Results will be reported in aggregate and de-identified form to protect participant confidentiality and privacy. Study records will be maintained in accordance with institutional policies
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 21 phase 1 interventional studies under Hypertension, Pulmonary, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Treprostinil
Valley Health System