Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05776225
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-03-01
Brief Title:
Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection PHINDER
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHINDER
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
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 Kings Brief Interstitial Lung Disease Questionnaire K-BILD 36-Item Short Form Survey SF-36 Pulmonary Hypertension Functional Classification Self Report PH-FC-SR Investigators 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
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 Kings Brief Interstitial Lung Disease Questionnaire K-BILD 36-Item Short Form Survey SF-36 Pulmonary Hypertension Functional Classification Self Report PH-FC-SR Investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None