The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hyp... | NCT03396120

Studies
The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease

NCT03396120

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jan 10, 2018Actual

Enrollment

95Actual

Phase

Not provided

Conditions

Interstitial Lung Disease
Pulmonary Hypertension

Interventions

Pulmonary function test

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2017Actual

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jan 5, 2018

First Submission Date that Met QC Criteria

Jan 5, 2018

First Posted Date

Jan 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2018

Last Update Posted Date

Jan 10, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pulmonary hypertension (PH) is a common disorder among patients with interstitial lung disease (ILD). The symptoms are usually nonspecific and overlooked. Thus, a noninvasive screening modality is recommended for early detection of PH because of its potentially significant impact on treatment strategy and clinical outcomes.

Objectives: To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary function test	Diagnostic Test	forced vital capacity and diffusing capacity		FVC/DLCO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
value of FVC/DLCO in predicting PAH in IPF	To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This retrospective study included all patients diagnosed with interstitial lung disease (ILD) who were followed up by the chest department of a tertiary hospital between September 2016 and January 2017

Exclusion Criteria:

patients with occupational history
collagen vascular disease predisposing them to lung disorders
patients who could not undergo pulmonary function testing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

- ILD was diagnosed on the basis of clinical, radiological and functional assessments

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AssiutU		Asyut		71111	Egypt
Pulmonology Departments

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012129	Respiratory Function Tests

Ancestor Terms

ID	Term
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided