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Prostacyclin Analogue

Inhaled Treprostinil for Pulmonary Hypertension

Phase 2
Recruiting
Led By Yogesh N Reddy, M.B.B.S
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 Years of Age
Patients with suspected Pulmonary Arterial Hypertension related to Interstitial Lung Disease (ILD-PAH) undergoing right heart catheterization.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-months
Awards & highlights

Study Summary

This trial is testing the effectiveness of treprostinil, given via inhaler, on patients with pulmonary arterial hypertension related to interstitial lung disease. The study will track exercise capacity and quality of life after 3 months.

Who is the study for?
Adults over 18 with suspected PAH-ILD undergoing right heart catheterization, and healthy volunteers without lung disease or pulmonary hypertension. It's not for anyone under 18.Check my eligibility
What is being tested?
The study is testing the drug treprostinil inhaled by patients with PAH-ILD to see how it affects their ability to exercise and quality of life after three months. Some may undergo optional muscle biopsies or RHC while exercising.See study design
What are the potential side effects?
Treprostinil may cause side effects such as headache, diarrhea, nausea, rash, jaw pain, flushing, increased cough or breathlessness during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am suspected to have high blood pressure in the lungs due to lung disease and will undergo a heart procedure.
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I am healthy with no lung, heart, muscle diseases or high blood pressure in the lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cardiac output reserve (Qc)
Secondary outcome measures
Change in New York Heart Association (NYHA) functional class
Change in exercise pulmonary artery pressure
Change in exercise pulmonary vascular resistance
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: PAH-ILD PatientsExperimental Treatment3 Interventions
Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy.
Group II: Healthy VolunteersExperimental Treatment2 Interventions
Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil
2021
Completed Phase 4
~180

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,766 Total Patients Enrolled
12 Trials studying Pulmonary Arterial Hypertension
1,659 Patients Enrolled for Pulmonary Arterial Hypertension
United TherapeuticsIndustry Sponsor
107 Previous Clinical Trials
13,369 Total Patients Enrolled
58 Trials studying Pulmonary Arterial Hypertension
8,211 Patients Enrolled for Pulmonary Arterial Hypertension
Yogesh N Reddy, M.B.B.SPrincipal InvestigatorMayo Clinic

Media Library

Treprostinil (Prostacyclin Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT05564637 — Phase 2
Pulmonary Arterial Hypertension Research Study Groups: Healthy Volunteers, PAH-ILD Patients
Pulmonary Arterial Hypertension Clinical Trial 2023: Treprostinil Highlights & Side Effects. Trial Name: NCT05564637 — Phase 2
Treprostinil (Prostacyclin Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05564637 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being recruited for this research project?

"This study, as listed on clinicaltrials.gov, is not currently looking for new participants. This trial was first posted on November 1st 2020 and was last edited September 29th 2020; however, there are many other trials (1108 to be exact) that are recruiting patients right now."

Answered by AI

Are patients with PAH-ILD at risk for developing serious complications?

"PAH-ILD Patients receive a 2 for safety because while there is some data supporting safety, none of it speaks to efficacy."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
Yogesh Reddy 2023. "A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05564637.
All > Lung Disease > Pulmonary Hypertension
~9 spots leftby Apr 2025
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