Renal Function in Adults With Congenital Heart Disease.
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|ClinicalTrials.gov Identifier: NCT00807274|
Recruitment Status : Withdrawn (Alternative trial planned)
First Posted : December 11, 2008
Last Update Posted : September 25, 2009
|Condition or disease|
|Cardiovascular Abnormalities Kidney Failure|
Renal dysfunction is a recognised independent prognosticator in patients with chronic heart failure. Indeed it has been suggested that the clinical impact of renal dysfunction may be greater than that of left ventricular ejection fraction per se.
The role of renal function has also been investigated in small sub-groups of patients with adult congenital heart disease (ACHD) for example peri-operatively. It is not however known if renal dysfunction has the same prevalence and significance as when present to patient with acquired heart failure. The hypothesis of the study is that renal dysfunction, both overt and sub-clinical, will be commonly detected in patients with congenital heart disease. The study proposes that renal dysfunction will be associated with hospitalisation for heart failure and fluid overload and will also identify patients at an increased risk of worsening clinical status.
Comparisons: Baseline renal function (creatinine, glomerular filtration rate by equation and clearance testing), quantification of urinalysis, baseline neurohormones. Follow-up data regarding clinical endpoints including new arrhythmia, functional deterioration, and hospitalisation.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Prospective Evaluation of Renal Function in Adults With Congenital Heart Disease.|
|Study Start Date :||September 2008|
|Estimated Study Completion Date :||December 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807274
|Adult Congenital Heart Disease Unit, Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Lorna Swan, MRCP MD||Royal Brompton & Harefield NHS Foundation Trust|