Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH

Completed

Conditions studied: Pulmonary Arterial Hypertension

In brief

This is an observational, multicenter, single-day, Phase 2 study. This study will include a 14-day Screening Period and Study Day 1 clinic visit. Participants will be required to perform an activity to induce symptoms of PAH, and participants' severity of self-reported symptoms of PAH will be measured from pre-activity, immediately after the activity, and through the 30-minute recovery. Participants will be asked about their PAH symptoms using 3 PGI-S questions that address their overall PAH symptoms, shortness of breath, and physical fatigue.

Key facts

Study ID

NCT03888365

Run by

United Therapeutics

People needed

43

Starts

2019-04-01

Expected to finish

2019-09-19

Last updated by the study team

2021-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant voluntarily gives informed consent to participate in the study.
• Males and females aged 18 years and above at the time of informed consent.
• Established primary diagnosis of PAH that is either idiopathic or familial PAH (WHO Group 1), collagen vascular disease associated PAH, PAH associated with HIV infection, PAH induced by anorexigens/toxins, or PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥1 years).
• Participant is deemed WHO Functional Class 1, 2, or 3.
• Participant has shortness of breath upon exertion (exhibits a ≥1-point change in Borg dyspnea score) as assessed by the ISWT and a minimum completion of 3 shuttles (30 meters) of the ISWT. Participant may have other symptoms as well.
• Participant is on stable dose of all FDA-approved PAH treatments (exceptions are anticoagulants and diuretics) for at least 60 days prior to Screening.
• In the opinion of the Investigator, the participant can communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements.

You may not qualify if…

• The participant is known to be pregnant or nursing.
• The participant has PAH related to any condition not covered under inclusion criteria, including, but not limited to, pulmonary venous hypertension, pulmonary venoocclusive disease, pulmonary capillary hemangiomatosis, chronic thromboembolic pulmonary hypertension, or other conditions under WHO Group 2, 3, 4, and 5 classifications.
• The participant has evidence of clinically significant left-sided heart disease (including, but not limited to, left ventricular ejection fraction <40%, left ventricular hypertrophy) or clinically significant cardiologic conditions, such as congestive heart failure, coronary artery disease, or valvular heart disease.
• The participant has any form of congenital heart disease (repaired or unrepaired; other than a patent foramen ovale).
• The participant has any ambulatory or orthopedic limitations that would interfere with the ability to perform the activity.
• The participant has been hospitalized within 30 days of Screening.
• Current use of prostacyclin analogs/agonists, except inhaled treprostinil, for the treatment of PAH.
• Use of any other investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days of Screening (concurrent participation in registry studies is allowed).
• Any other clinically significant illness that, in the opinion of the Investigator, might put the participant at risk of harm during the study or might adversely affect the interpretation of the study data.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Beverly Hills, California, United States
• Santa Barbara Pulmonary Associates — Santa Barbara, California, United States
• St. Francis Sleep, Allergy & Lung Institute — Clearwater, Florida, United States
• Pulmonary & Critical Care of Atlanta — Atlanta, Georgia, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Pulmonary Health Physicians, PC — Fayetteville, New York, United States
• The Mount Sinai Hospital — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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