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Renal Function in Adults With Congenital Heart Disease.
This study is currently recruiting participants.
Verified by Royal Brompton Hospital NHS Trust, December 2008
First Received: December 10, 2008   No Changes Posted
Sponsored by: Royal Brompton Hospital NHS Trust
Information provided by: Royal Brompton Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00807274
  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: Cohort, 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 Hospital NHS Trust:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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

Contacts
Contact: Lorna Swan, MRCP MD 44 (0)2073487748 L.Swan@rbht.nhs.uk
Contact: Michael Gatzoulis, MD PhD 44 (0)2073518602 M.Gatzoulis@rbht.nhs.uk

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

No publications provided

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

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

Study placed in the following topic categories:
Renal Insufficiency
Heart Failure
Proteinuria
Heart Diseases
Urologic Diseases
Cardiovascular Abnormalities
Kidney Diseases
Congenital Abnormalities
Heart Defects, Congenital
Kidney Failure

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

ClinicalTrials.gov processed this record on July 02, 2009