- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807274
Renal Function in Adults With Congenital Heart Disease.
Prospective Evaluation of Renal Function in Adults With Congenital Heart Disease.
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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London, United Kingdom, SW3 6NP
- Adult Congenital Heart Disease Unit, Royal Brompton Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Lorna Swan, MRCP MD, Royal Brompton & Harefield NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06/Q0404/75
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