NCT03396120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

January 5, 2018

Last Update Submit

January 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

forced vital capacity and diffusing capacity

Also known as: FVC/DLCO

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AssiutU

Asyut, 71111, Egypt

Location

Pulmonology Departments

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Lung Diseases, InterstitialHypertension, Pulmonary

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pulmonology

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 10, 2018

Study Start

February 2, 2017

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations