Renal Function in Adults With Congenital Heart Disease.

Kidney Failure Clinical Trial

Official title:

Prospective Evaluation of Renal Function in Adults With Congenital Heart Disease.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00807274
• Other study ID #: 06/Q0404/75
• Status: Withdrawn
• Phase: N/A
• First received: December 10, 2008
• Last updated: September 24, 2009
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2009
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 1200
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Heart Defects, Congenital
• Heart Diseases
• Kidney Failure
• Renal Insufficiency

Locations

Country	Name	City	State
United Kingdom	Adult Congenital Heart Disease Unit, Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,