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

Pulmonary Hypertension Clinical Trial

— PHINDER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776225
• Other study ID #: GMS-PH-001
• Status: Recruiting
• Start date: August 11, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2024
• Source: United Therapeutics
• Contact: United Therapeutics Global Medical Information
• Phone: 919-485-8350
• Email: clinicaltrials[@]unither.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Hypertension

Intervention

Procedure:
• Right heart catheterization (RHC)
RHC to evaluate pulmonary hemodynamics

Locations

Country	Name	City	State
United States	AnMed Health Pulmonary and Sleep Medicine	Anderson	South Carolina
United States	University of Michigan Int Med Pulmonary and critical care	Ann Arbor	Michigan
United States	Piedmont Healthcare	Austell	Georgia
United States	Loyola University Chicago	Chicago	Illinois
United States	Prisma Health	Columbia	South Carolina
United States	Premier Pulmonary Critical Care and Sleep Medicine	Denison	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Pulmonix, LLC	Greensboro	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Houston Methodist Hospital	Houston	Texas
United States	Marshall Health	Huntington	West Virginia
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Intermountain Healthcare	Murray	Utah
United States	NCH Healthcare System	Naples	Florida
United States	LSU Health Sciences Center New Orleans	New Orleans	Louisiana
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Mclaren Greater Lansing	Okemos	Michigan
United States	Pulmonary Associates	Phoenix	Arizona
United States	Legacy Health	Portland	Oregon
United States	Pulmonary Associates of Richmond	Richmond	Virginia
United States	University of Utah Health	Salt Lake City	Utah
United States	Providence Medical Research Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with PH as indicated by RHC	Mean pulmonary artery pressure (mPAP) >20 mmHg with pulmonary artery wedge pressure (PAWP) =15 mmHg and pulmonary vascular resistance (PVR) =2 WU.	Through study completion, approximately 3 weeks.
Secondary	Percentage of patients with severe PH as indicated by RHC	mPAP >20 mmHg with PAWP =15 mmHg and PVR >5 WU.	Through study completion, approximately 3 weeks.