Natural Course for Renal Function After Heart Transplantation

NCT ID: NCT02541981

Last Updated: 2015-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-07-31

Brief Summary

The outcome of heart transplantation has improved by years. The renal dysfunction is a major complication after heart transplantation.The natural course of renal function following orthotopic heart transplant is not clear in Taiwan. A retrospective study was conducted on patients who received a heart transplant at National Taiwan University Hospital between 1987 and 2015.

Detailed Description

The investigators conducted a retrospective cohort study of patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015 . Clinical data were obtained and a retrospective chart review, and were collected up to 10 years .

Data was collected from medical records and the heart transplant electronic database including: demographic parameters such as age and gender; etiology of heart failure; the presence of any of the following comorbidities: history of smoking, diabetes, hypertension, peripheral vascular disease and previous sternotomy; pre-transplant cholesterol levels; the use of any of the following pretransplant hemodynamic support measures:intravenous inotropes, intra-aortic balloon pump and ventricular assist device;creatinine levels; listing status according to the UNOS classification; waiting time; heart ischemic time;immunosuppression drug levels(cyclosporine,prograft or certican) and development of end stage renal disease requiring onset of dialysis therapy.

Creatinine levels and GFRwere collected before transplantation and then the closest level to every month after heart transplant.

The clinical outcomes of interest analyzed in this study included the development of post-transplant end stage renal disease and death.

Conditions

Creatinine Clearance Quantitative Trait Locus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

This study included patients with a first HTx performed at NTUH between1987 and 2015.

Exclusion Criteria

Patients were excluded if their first HTx was a combined transplant involving a KTx, they had renal replacement therapy prior to their HTx.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen Cheryl Chia-Hui, PHD

Role: PRINCIPAL_INVESTIGATOR

Professor , School of Nursing, National Taiwan University

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201507087RIND

Identifier Type: -

Identifier Source: org_study_id