Renal Function in Adults With Congenital Heart Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00807274
Recruitment Status : Withdrawn (Alternative trial planned)
First Posted : December 11, 2008
Last Update Posted : September 25, 2009
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust

Brief 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.

Condition or disease
Cardiovascular Abnormalities Kidney Failure

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 : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Renal Function in Adults With Congenital Heart Disease.
Study Start Date : September 2008
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples Without DNA
Plasma, serum and urine samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00807274

United Kingdom
Adult Congenital Heart Disease Unit, Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Lorna Swan, MRCP MD Royal Brompton & Harefield NHS Foundation Trust

Responsible Party: Dr Lorna Swan, Royal Brompton Hospital Identifier: NCT00807274     History of Changes
Other Study ID Numbers: 06/Q0404/75
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: September 25, 2009
Last Verified: September 2009

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Adult congenital heart disease
Heart failure
Renal failure

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Renal Insufficiency
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Kidney Diseases
Urologic Diseases