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Clinical Trials/NCT00905463
NCT00905463UnknownNot Applicable

Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates

Kyoto University, Graduate School of Medicine4 sites in 1 country272 target enrollmentStarted: April 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
272
Locations
4
Primary Endpoint
Prognosis/Mortality

Study Overview

Brief Summary

The purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in Japan.

Detailed Description

The significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. Therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • New lung transplant candidates

Exclusion Criteria

  • Heart and lung transplant candidates
  • Uncontrolled severe comorbidities

Outcomes

Primary Outcomes

Prognosis/Mortality

Time Frame: 5 years

Secondary Outcomes

  • Arterial blood gas(At entry and every year for 5 years)
  • Health status(At entry and every year for 5 years)
  • Dyspnea(At entry and every year for 5 years)
  • Psychological status(At entry and every year for 5 years)
  • Sleep quality(At entry and every year for 5 years)
  • Pulmonary function(At entry and every year for 5 years)

Investigators

Sponsor
Kyoto University, Graduate School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Toru Oga

Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine

Kyoto University, Graduate School of Medicine

Study Sites (4)

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