A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension

Study Purpose

The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in participants with pulmonary arterial hypertension (PAH).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Confirmed PAH (WHO Group 1) classified by one of the following subgroups: - Idiopathic, heritable or drug/toxin induced (with the exception of amphetamine-induced PAH) - Associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥1 year) - Associated with connective tissue disease.
  • - Associated with human immunodeficiency virus infection.
  • - Baseline visit right heart catheterization (RHC) must also meet the following criteria: - mPAP >35 mmHg.
  • - Pulmonary vascular resistance (PVR) ≥3 Wood units.
  • - Pulmonary artery wedge pressure (PAWP) ≤15 mmHg.
  • - Treatment naïve or on a stable dose of an endothelin receptor antagonist (ERA) and/or phosphodiesterase type 5 inhibitor (PDE-5i) for ≥30 days, but <6 months prior to the Baseline visit.
  • - REVEAL Lite 2 risk score ≤9.
  • - WHO FC II or III.
  • - 6MWD >165 meters.

Exclusion Criteria:

PAH-related

Exclusion Criteria:

  • - Prior or current use of epoprostenol, treprostinil, iloprost, beraprost, or selexipag.
  • - Positive vasoreactivity test in idiopathic, heritable, or drug/toxin induced PAH.
  • - Amphetamine use within the past 12 months.
  • - WHO Groups 2, 3, 4, and 5.
  • - Use of any other investigational drug, device, or therapy within 30 days of the Baseline visit.
  • - Moderate or severe hepatic impairment (Child-Pugh Class B and C) - Any other clinically significant illness or abnormal laboratory value(s) measured during screening that, in the opinion of the Investigator, might adversely affect interpretation of the study data or subject safety (for example, active infection, chronic thromboembolic pulmonary hypertension, or acute/recent deep vein thrombosis or pulmonary embolism) cMRI-related

    Exclusion Criteria:

    - Chronic atrial fibrillation, multiple premature ventricular or atrial contractions of clinical significance, or any other condition that would interfere with proper cardiac gating during cMRI.
  • - Permanent cardiac pacemaker or automatic internal cardioverter that would interfere with conduct of cMRI.
  • - Metallic implant (for example, defibrillator, neurostimulator, hearing aid, permanent infusion device, implantable pump, or body plates/screws/bolts) that would interfere with conduct of cMRI.
CardioMEMS-related Exclusion Criteria, if applicable:
  • - Previously implanted with CardioMEMS pulmonary artery Sensor or unwilling/unable to permit collection and perform upload (transmission) of pulmonary artery pressure (PAP) readings.
  • - Unable to take dual antiplatelet or anticoagulation therapy for 30 days after CardioMEMS PA Sensor implantation unless the participant has an indication for warfarin or direct oral anticoagulant.
NOTE: Other inclusion and exclusion criteria may apply.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05203510
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

United Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

Experimental: Treprostinil

Participants will receive parenteral treprostinil at an initial dose of 1.25 nanograms (ng)/kilogram (kg)/minute (min) (or 0.625 ng/kg/min, if initial dose is not tolerated) either intravenously (IV) or subcutaneously (SC). Based on Month 6 mPAP assessment or earlier at Investigator's discretion and after a target dose is reached, participants may transition to oral treprostinil 3 times daily (TID) and continue up-titration in dose towards further reduction of mPAP or participants may continue up-titration of parenteral treprostinil until Month 12. Following completion of all Month 12 assessments, at Investigator's discretion, participants may transition from parenteral to oral treprostinil TID and continue up-titration for further reduction of mPAP. Treprostinil therapy (parenteral or oral) may continue, as tolerated, towards the goal of further reduction of mPAP until Month 36.

Interventions

Drug: - Parenteral Treprostinil

Parenteral treprostinil will be administered per schedule specified in the arm description.

Drug: - Oral Treprostinil

Oral treprostinil will be administered per schedule specified in the arm description.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Henry Ford Health System, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Health System

Detroit, Michigan, 48202

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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