Renal Function in Adults With Congenital Heart Disease.
NCT ID: NCT00807274
Last Updated: 2009-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
1200 participants
OBSERVATIONAL
2008-09-30
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
* Congenital heart disease being treated as an outpatient
Exclusion Criteria
* Renal failure requiring renal-replacement therapy
* Known diabetes
* Shellfish, iodine, or significant drug allergy (sub-study only).
18 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Royal Brompton Hospital
Principal Investigators
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Lorna Swan, MRCP MD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
Locations
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Adult Congenital Heart Disease Unit, Royal Brompton Hospital
London, London, United Kingdom
Countries
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Other Identifiers
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06/Q0404/75
Identifier Type: -
Identifier Source: org_study_id
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