Prognosis of Lung Transplant Candidates
This study is currently recruiting participants.
Verified March 2013 by Kyoto University, Graduate School of Medicine
Sponsor:
Kyoto University, Graduate School of Medicine
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00905463
First received: May 18, 2009
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Transplantation Respiratory Failure |
Procedure: Lung transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates |
Resource links provided by NLM:
Further study details as provided by Kyoto University, Graduate School of Medicine:
Primary Outcome Measures:
- Prognosis/Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Health status [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
- Dyspnea [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
- Psychological status [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
- Sleep quality [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
- Pulmonary function [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
- Arterial blood gas [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Transplantation
Lung transplantation candidates
|
Procedure: Lung transplantation
Lung transplantation
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
University hospital clinic for lung transplantation
Criteria
Inclusion Criteria:
- New lung transplant candidates
Exclusion Criteria:
- Heart and lung transplant candidates
- Uncontrolled severe comorbidities
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905463
Contacts
| Contact: Fengshi Chen, MD, PhD | +81 75 751 4975 | fengshic@kuhp.kyoto-u.ac.jp |
| Contact: Toru Oga, MD, PhD | +81 75 751 3852 | ogato@kuhp.kyoto-u.ac.jp |
Locations
| Japan | |
| Graduate School of Medicine, Kyoto University | Recruiting |
| Kyoto, Japan | |
| Contact: Fengshi Chen, MD, PhD +81 75 751 4975 fengshic@kuhp.kyoto-u.ac.jp | |
| Contact: Toru Oga, MD, PhD +81 75 751 3852 ogato@kuhp.kyoto-u.ac.jp | |
| Sub-Investigator: Toru Bando, MD | |
| Sub-Investigator: Izumi Matsumoto | |
| Sub-Investigator: Hiroaki Sakai, MD | |
| Okayama University | Recruiting |
| Okayama, Japan | |
| Principal Investigator: Takahiro Oto, MD | |
| Tohoku University | Recruiting |
| Sendai, Japan | |
| Principal Investigator: Katsunori Okada, M.D. | |
| Osaka University | Recruiting |
| Suita, Japan | |
| Principal Investigator: Masato Minami, MD | |
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Ministry of Health, Labour and Welfare, Japan
Investigators
| Study Chair: | Hiroshi Date, MD, PhD | Graduate School of Medicine, Kyoto University |
More Information
No publications provided
| Responsible Party: | Toru Oga, Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine, Kyoto University, Graduate School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00905463 History of Changes |
| Other Study ID Numbers: | E554kyoto |
| Study First Received: | May 18, 2009 |
| Last Updated: | March 25, 2013 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Kyoto University, Graduate School of Medicine:
|
Lung transplant candidates Health-related quality of life patient reported outcome Prognosis |
Additional relevant MeSH terms:
|
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013