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Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection
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).
Conditions:
🦠 Interstitial Lung Disease 🦠 Pulmonary Hypertension
🗓️ Study Start (Actual) 11 August 2023
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 1 February 2025
👥 Enrollment (Estimated) 200
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Phoenix, Arizona, United States
📍 Hartford, Connecticut, United States
📍 Naples, Florida, United States
📍 Tampa, Florida, United States
📍 Austell, Georgia, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 New Orleans, Louisiana, United States
📍 Ann Arbor, Michigan, United States
📍 Okemos, Michigan, United States
📍 Lebanon, New Hampshire, United States
📍 Durham, North Carolina, United States
📍 Greensboro, North Carolina, United States
📍 Greenville, North Carolina, United States
📍 Portland, Oregon, United States
📍 Anderson, South Carolina, United States
📍 Columbia, South Carolina, United States
📍 Denison, Texas, United States
📍 Houston, Texas, United States
📍 San Antonio, Texas, United States
📍 Murray, Utah, United States
📍 Salt Lake City, Utah, United States
📍 Falls Church, Virginia, United States
📍 Norfolk, Virginia, United States
📍 Richmond, Virginia, United States
📍 Spokane, Washington, United States
📍 Huntington, West Virginia, United States
📍 Milwaukee, Wisconsin, United States
More locations available...

📋 Eligibility Criteria

Description

  • 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 March 2023
  • First Submitted that Met QC Criteria 16 March 2023
  • First Posted 20 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 July 2024
  • Last Update Posted 25 July 2024
  • Last Verified July 2024
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