Effects of Inhaled Treprostinil on Exercise Performance in Exercise Induced Pulmonary Hypertension

NCT07116681 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 813050ISS-2025-0061
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to investigate therapies for exercise induced pulmonary hypertension (EiPH). This is a condition that effects the blood vessels in the lungs and causes shortness of breath with activity. Currently, there are very limited treatment options for this condition. Inhaled treprostinil, also known as Tyvaso, is a medication used to treat other forms of lung disease and is safe and well tolerated. This study will measure the ability of Tyvaso to improve symptoms related to EiPH and improve performance on exercise testing.

Conditions

Pulmonary Hypertension

Keywords

Exercise Induced Pulmonary Hypertension; Tyvaso; Inhaled treprostinil; Cardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (1)

• Stroke volume augmentation before and after inhaled treprostinil

  Stroke volume augmentation is a physiologic parameter which reflects the hearts ability to respond to physiologic demands of exercise. Stroke volume can be inferred during cardiopulmonary exercise testing by calculating the O2 pulse. Oxygen uptake (VO2) and heart rate are directly measured during cardiopulmonary exercise testing. O2 pulse is calculated by dividing VO2 by heart rate. Stroke volume augmentation is the ratio of O2 pulse at baseline (at the beginning of exercise) and at anaerobic threshold. Stroke volume augmentation will be measured before and after treatment with inhaled treprostinil to assess for improvements in heart function during exercise.

  30 minutes after initial dose of inhaled treprostinil

Secondary Outcomes (3)

• PAH Sympact Scoring

  8 weeks

• Long term stroke volume augmentation

  8 weeks

• Dead space ventilation

  30 minutes, 8 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

Single arm, every participant will receive inhaled treprostinil

Drug: Inhaled treprostinil

Interventions

Inhaled treprostinil DRUG

Inhaled treprostinil is an inhaled prostacyclin analog which triggers pulmonary arterial dilation. This is the only intervention in this trial.

Also known as: tyvaso

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Persons, aged 18 years of older
• Established diagnosis of exercise induced pulmonary hypertension defined by the following:
• Invasive cardiopulmonary exercise testing demonstrating a mean pulmonary artery pressure to cardiac output (P/Q slope) greater than 3 mmHg/L/min
• Symptoms of exertional dyspnea
• Ability to perform non-invasive cardiopulmonary exercise testing, either on upright bicycle or treadmill
• If childbearing age, patient must agree to use of effective contraception during the trial

You may not qualify if:

• Diagnosis of pulmonary hypertension as defined by resting mean pulmonary arterial pressure of ≥ 20 mmHg, PVR \> 3
• Severe underlying chronic lung disease (e.g. COPD, interstitial lung disease)
• Underlying chronic left ventricular disease (e.g. heart failure with reduced ejection fraction)
• Chronic thromboembolic disease
• Pregnancy
• Acute infectious symptoms including fevers within the last week
• Inability or unwillingness to discontinue any phosphodiesterase 5 inhibitors or other off-label
• Known allergic reactions to inhaled treprostinil
• Inability to comply with study protocols

Sponsors & Collaborators

• University of California, San Diego: lead
• United Therapeutics: collaborator

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Timothy Fernandes, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew D Rockstrom, MD

CONTACT

15093781906; mrockstrom11@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD and supporting information will be available from trial start date (previously specified) until two years after study completion date (previously specified)
• Access Criteria: IPD will be stored on a password protected RedCap database and analyzed on password protected and encrypted devices belonging to the University of California, San Diego or the study team. Only members of the study team will be able to access IPD. Any other dissemination of IPD will be shared in a manner that is de-identified. Publication of individual results may occur but this will be presented in a de-identified manner (ie through individual data points on a spaghetti plot).