Natural Course for Renal Function After Heart Transplantation

Creatinine Clearance Quantitative Trait Locus Clinical Trial

Official title:

Natural Course for Renal Function After Heart Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02541981
• Other study ID #: 201507087RIND
• Status: Active, not recruiting
• Phase: N/A
• First received: August 31, 2015
• Last updated: September 10, 2015
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Creatinine Clearance Quantitative Trait Locus

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural course for renal function (ex blood creatine leveal ,eGFR) after heart transplantation	the outcome measure is assessed up to 10 years	patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015	Yes