NCT05776225

Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection

Official Title:

Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)

Summary

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).

Eligibility

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.

Disease(s) and\or Condition(s)

Interstitial Lung Disease

Pulmonary Hypertension

Primary Purpose
Intervention/Treatment
    • Type: PROCEDURE
    • Name: Right heart catheterization (RHC)
    • Description: RHC to evaluate pulmonary hemodynamics
    • Arm Group Labels: Experimental study arm
Sponsor
  • United Therapeutics