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Renal Function in Adults With Congenital Heart Disease.
This study has been withdrawn prior to recruitment.
( Alternative trial planned )
Study NCT00807274   Information provided by Royal Brompton & Harefield NHS Foundation Trust
First Received: December 10, 2008   Last Updated: September 24, 2009   History of Changes

December 10, 2008
September 24, 2009
September 2008
 
 
 
Complete list of historical versions of study NCT00807274 on ClinicalTrials.gov Archive Site
 
 
 
Renal Function in Adults With Congenital Heart Disease.
Prospective Evaluation of Renal Function in Adults With Congenital Heart Disease.

Impaired kidney function is associated with a poor outcome in patients with heart failure but it is not known of this is the case for patients who have been born with their heart condition (congenital heart disease). This study aims to investigate how frequently patients with congenital heart disease have kidney disease and whither this does have an impact on their outcome. The hypothesis is that kidney dysfunction will be common in these patients and may have an impact on long-term health and life-expectancy.

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.

 
Observational
Cohort, Prospective
  • Cardiovascular Abnormalities
  • Kidney Failure
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Withdrawn
1200
December 2010
 

Inclusion Criteria:

  • The ability to give informed consent
  • Age >18 years
  • Congenital heart disease being treated as an outpatient

Exclusion criteria:

  • Pregnancy
  • Renal failure requiring renal-replacement therapy
  • Known diabetes
  • Shellfish, iodine, or significant drug allergy (sub-study only).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00807274
Dr Lorna Swan, Royal Brompton Hospital
06/Q0404/75
Royal Brompton & Harefield NHS Foundation Trust
 
Principal Investigator: Lorna Swan, MRCP MD Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP