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WithdrawnNCT00807274Updated Sep 25, 2009

Renal Function in Adults With Congenital Heart Disease.

An observational study in Cardiovascular Abnormalities and Kidney Failure, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-25.

Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Observational

Why this study was withdrawn
Alternative trial planned
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Abnormalities
  • Kidney Failure

Keywords

  • Adult congenital heart disease
  • Heart failure
  • Renal failure
  • Proteinuria
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stable adult patients with congenital heart disease

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Pregnancy
  • Renal failure requiring renal-replacement therapy
  • Known diabetes
  • Shellfish, iodine, or significant drug allergy (sub-study only).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Biospecimen retention
Samples without dna
06

Study locations

1 site
  • Adult Congenital Heart Disease Unit, Royal Brompton Hospital
    London, SW3 6NP, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00807274
Lead sponsor
Royal Brompton & Harefield NHS Foundation Trust
First posted
Dec 11, 2008
Start date
Sep 2008
Completion
Dec 2010 (estimated)
Last update
Sep 25, 2009

Study contacts

Lorna Swan, MRCP MD
principal investigator · Royal Brompton & Harefield NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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