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

Sponsor

United Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05776225

Collaborator

(none)

200

Enrollment

10.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease Pulmonary Hypertension	Procedure: Right heart catheterization (RHC)

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental study arm All enrolled patients in this single arm study will receive a RHC.	Procedure: Right heart catheterization (RHC) RHC to evaluate pulmonary hemodynamics

Arm

Intervention/Treatment

Experimental study arm

All enrolled patients in this single arm study will receive a RHC.

Procedure: Right heart catheterization (RHC)

RHC to evaluate pulmonary hemodynamics

Outcome Measures

Primary Outcome Measures

Percentage of patients with PH as indicated by RHC [Through study completion, approximately 3 weeks.]
Mean pulmonary artery pressure (mPAP) >20 mmHg with pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 WU.

Secondary Outcome Measures

Percentage of patients with severe PH as indicated by RHC [Through study completion, approximately 3 weeks.]
mPAP >20 mmHg with PAWP ≤15 mmHg and PVR >5 WU.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patient gives voluntary written informed consent to participate in the study.
Patients with a diagnosis of ILD based on computed tomography imaging, including:
Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
Connective tissue disease-associated ILD with forced vital capacity (FVC) <70%
Hypersensitivity pneumonitis
Scleroderma-related ILD
Autoimmune ILD
Nonspecific interstitial pneumonia
Occupational lung disease
Combined pulmonary fibrosis and emphysema
Patients must have at least 2 signs or symptoms suggestive of PH, as specified by the study protocol.

Exclusion Criteria

Prior RHC with mPAP >20 mmHg.
Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial hypertension medication.
Diagnosed with chronic obstructive pulmonary disease.
Uncontrolled or untreated sleep apnea.
Pulmonary embolism within the past 3 months.
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.
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.