Validation of the Risk Stratification Score in Idiopathic Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT02632123|
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : December 10, 2020
Idiopathic pulmonary fibrosis (IPF) is a progressing scarring disease of the lungs with an average survival of only 30-36 months since the time of diagnosis, in the absence of treatment. The clinical course of IPF is highly variable, with some patients remaining stable for a prolonged period of time, even in the absence of medical treatment, while others experience rapid and relentless progression. In some cases, the clinical course consists of a stepwise rather than steady decline, with periods of stability alternating with acute respiratory worsening. The variability in clinical course makes it challenging to define prognosis in these patients and, importantly, to determine the right time window for lung transplantation (LTx) referral, listing and priority status on the waiting list.
The risk stratification score (RISE) is a new, multi-dimensional staging system for IPF based on the MRC dyspnea score, on physiology variables (pulmonary function tests) captured in the Composite Physiologic Index (CPI), and on the 6-minute walk distance. RISE showed to predict survival in newly diagnosed patients with IPF better than any other individual clinical, functional or radiographic variable. RISE also predicted survival on the waiting list in patients assessed and listed for LTx. The objective of this study is to validate this staging system in a large cohort of patients newly diagnosed with IPF and followed for at least 3 years.
|Condition or disease|
|Idiopathic Pulmonary Fibrosis|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Validation of the Risk Stratification Score in Idiopathic Pulmonary Fibrosis|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Idiopathic pulmonary fibrosis
Patients newly diagnosed with idiopathic pulmonary fibrosis
- Survival [ Time Frame: 3 years ]Primary outcome is 3-year survival since the time of diagnosis
- Acute exacerbation of IPF [ Time Frame: 3 years ]Secondary outcome is the incidence of acute exacerbations since the time of diagnosis
- Clinical progression [ Time Frame: 3 years ]Time to either: decline of FVC >10% pred; decline of 6-min walk distance >50 m; hospitalization for respiratory causes; lung transplant assessment; or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632123
|Contact: Marco Mura, MD, PhDemail@example.com|
|London Health Science Centre||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Marco Mura, MD, PhD +15196676744 firstname.lastname@example.org|
|Contact: Mena Gaed, MBCCh, MSc +15196858500 ext 73451 email@example.com|
|Principal Investigator: Marco Mura, MD, PhD|