Renal Function in Adults With Congenital Heart Disease.

This study has been withdrawn prior to enrollment.
(Alternative trial planned)
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00807274
First received: December 10, 2008
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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
Cardiovascular Abnormalities
Kidney Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Renal Function in Adults With Congenital Heart Disease.

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Biospecimen Retention:   Samples Without DNA

Plasma, serum and urine samples


Estimated Enrollment: 1200
Study Start Date: September 2008
Estimated Study Completion Date: December 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stable adult patients with congenital heart disease

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807274

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

No publications provided

Responsible Party: Dr Lorna Swan, Royal Brompton Hospital
ClinicalTrials.gov Identifier: NCT00807274     History of Changes
Other Study ID Numbers: 06/Q0404/75
Study First Received: December 10, 2008
Last Updated: September 24, 2009
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 30, 2014