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Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection
Study Purpose
Study GMS-PH-001 is a multicenter, open-label, non-randomized study to prospectively evaluate
screening strategies of pulmonary hypertension (PH) in patients with interstitial lung
disease (ILD).
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.
Observational
Eligible Ages
18 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria. 1. Patient gives voluntary written informed consent to participate in the study.
2. Patients with a diagnosis of ILD based on computed tomography imaging, including:
1. Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis. 2. Connective tissue disease-associated ILD with forced vital capacity (FVC) <70%
3. Hypersensitivity pneumonitis. 4. Scleroderma-related ILD. 5. Autoimmune ILD. 6. Nonspecific interstitial pneumonia. 7. Occupational lung disease. 8. Combined pulmonary fibrosis and emphysema. 3. Patients must have at least 2 signs or symptoms suggestive of PH, as specified by the
study protocol.
Exclusion Criteria. 1. Prior RHC with mPAP >20 mmHg.
2. Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial
hypertension medication.
3. Diagnosed with chronic obstructive pulmonary disease.
4. Uncontrolled or untreated sleep apnea.
5. Pulmonary embolism within the past 3 months.
6. History of ischemic heart disease or left-sided myocardial dysfunction within 12
months of Screening, defined as left ventricular ejection fraction <40% or pulmonary
capillary wedge pressure >15 mmHg.
7. Any other clinical features that, in the opinion of the Investigator, might adversely
affect interpretation of study data or study safety, or make the patient unsuitable
for RHC.
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.
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.
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.
Interstitial Lung Disease, Pulmonary Hypertension
Additional Details
In this study, subjects will undergo a broad range of clinical assessments that are
potentially associated with PH. Study data will be used to identify and weigh specific
clinical parameters based on their prognostic significance for right heart catheterization
(RHC)-confirmed PH. There is no study drug under investigation in this study. The study
consists of 2 study visits: a Screening Visit and Study Visit 1.
Clinical assessments include pulmonary function tests (PFTs); high resolution computed
tomography (HRCT); physical examination; 6-Minute Walk Test; blood draw for clinical
laboratory parameters, plasma brain natriuretic peptide (BNP) concentration and plasma
N-terminal pro-BNP (NT-proBNP) concentration; echocardiography; University of California San
Diego Shortness of Breath Questionnaire (UCSD SOBQ); King's Brief Interstitial Lung Disease
Questionnaire (K-BILD); 36-Item Short Form Survey (SF-36); Pulmonary Hypertension Functional
Classification Self Report (PH-FC-SR); Investigator's Suspicion of PH Questionnaire; adverse
event (AE) monitoring; and RHC.
As the primary objective of this study is to collect a broad range of clinical parameters in
patients with ILD, it is expected that numerous exploratory and post-hoc analyses will be
performed to identify and weigh specific parameters based on their prognostic significance
for PH in this patient population with the goal of developing a screening algorithm for PH in
patients with ILD.
Arms & Interventions
Arms
: Experimental study arm
All enrolled patients in this single arm study will receive a RHC.
Interventions
Procedure: - Right heart catheterization (RHC)
RHC to evaluate pulmonary hemodynamics
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.
