RECRUITINGOBSERVATIONAL
Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection
Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)
About This Trial
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).
Who May Be Eligible (Plain English)
Inclusion Criteria
1. Patient gives voluntary written willing to sign a consent form to participate in the study and are capable of reading and understanding questionnaires or forms in English or Spanish.
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 with mild emphysema on lung imaging as determined by the Investigator
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 (PAH) medication for the treatment of PAH.
3. Diagnosed with chronic obstructive pulmonary disease (CPFE with mild emphysema notwithstanding).
4. Uncontrolled or untreated moderate to severe sleep apnea as determined by the patient's physician.
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 or HRCT (e.g., pregnancy).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria
1. Patient gives voluntary written informed consent to participate in the study and are capable of reading and understanding questionnaires or forms in English or Spanish.
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 with mild emphysema on lung imaging as determined by the Investigator
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 (PAH) medication for the treatment of PAH.
3. Diagnosed with chronic obstructive pulmonary disease (CPFE with mild emphysema notwithstanding).
4. Uncontrolled or untreated moderate to severe sleep apnea as determined by the patient's physician.
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 or HRCT (e.g., pregnancy).
Treatments Being Tested
PROCEDURE
Right heart catheterization (RHC)
RHC to evaluate pulmonary hemodynamics
Locations (20)
Pulmonary Associates
Phoenix, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Lakeland Regional Health
Lakeland, Florida, United States
NCH Healthcare System
Naples, Florida, United States
University of South Florida Health
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Healthcare
Austell, Georgia, United States
Loyola University Chicago
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
NorthShore University Health System
Glenview, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, United States
University of Michigan Int Med Pulmonary and Critical Care
Ann Arbor, Michigan, United States
Mclaren Greater Lansing
Okemos, Michigan, United States
Blessing Health Hannibal
Hannibal, Missouri, United States
Renown Regional Medical Center
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States