Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416163
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-01-19
Brief Title:
FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
A Prospective Observational Study Investigating Whether Nocturnal Hypoxaemia and Exercise Induced Desaturation Predict Functional Deterioration in Patients With Fibrotic Interstitial Lung Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
FIBRINOX-EXTRA
Brief Summary:
This is an observational clinical research study investigating patients with fibrotic interstitial lung disease fILD also known as pulmonary fibrosis
It is not known why some patients with fILD clinically deteriorate This study will investigate whether measuring oxygen levels during sleep or exercise can help identify patients who are at increased risk of clinical deterioration
It is not known why some patients with fILD clinically deteriorate This study will investigate whether measuring oxygen levels during sleep or exercise can help identify patients who are at increased risk of clinical deterioration
Detailed Description:
This work will build upon the FIBRINOX study previous clinical research conducted by the Guys and St Thomas ILD research team The FIBRINOX study showed that patients with fILD and normal oxygen saturations at rest but who desaturate whilst asleep or during exercise have a significantly increased mortality and greater reduction in quality of life compared to patients who do not desaturate at night or during exercise
The reasons for these differences in mortality and health related quality of life are not known Data suggests that worsening fILD and the development of pulmonary hypertension a condition characterised by increased pressure in the pulmonary arteries that is associated with poorer outcomes may be playing a role
This clinical research study will recruit approximately 160 patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease fILD Data from routinely performed investigations as part of tertiary ILD assessment will be systematically recorded
Investigations will include lung function tests echocardiography blood tests a 6-minute walk test and overnight oximetry Participants will also complete several quality-of-life questionnaires These investigations will be performed at baseline and again at 12 months with all tests also repeated at 6 months except for an echocardiogram After the initial 1 year study period a 3 year post-recruitment mortality and right heart catheter check will be performed using the participants medical records Data will be collected from CT scans and right heart catheters if performed during the study period as part of the participants usual clinical care
This study is designed to establish whether patients with fILD who desaturate during sleep or exercise are more likely to experience functional decline as well as confirm previous findings of increased mortality and worsening quality of life as demonstrated in the FIBRINOX study The data generated by this observational study will help generate future hypotheses research questions and clinical study
The reasons for these differences in mortality and health related quality of life are not known Data suggests that worsening fILD and the development of pulmonary hypertension a condition characterised by increased pressure in the pulmonary arteries that is associated with poorer outcomes may be playing a role
This clinical research study will recruit approximately 160 patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease fILD Data from routinely performed investigations as part of tertiary ILD assessment will be systematically recorded
Investigations will include lung function tests echocardiography blood tests a 6-minute walk test and overnight oximetry Participants will also complete several quality-of-life questionnaires These investigations will be performed at baseline and again at 12 months with all tests also repeated at 6 months except for an echocardiogram After the initial 1 year study period a 3 year post-recruitment mortality and right heart catheter check will be performed using the participants medical records Data will be collected from CT scans and right heart catheters if performed during the study period as part of the participants usual clinical care
This study is designed to establish whether patients with fILD who desaturate during sleep or exercise are more likely to experience functional decline as well as confirm previous findings of increased mortality and worsening quality of life as demonstrated in the FIBRINOX study The data generated by this observational study will help generate future hypotheses research questions and clinical study
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