Renal Function in Adults With Congenital Heart Disease.

Sponsor
Royal Brompton & Harefield NHS Foundation Trust (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00807274
Collaborator
(none)
1,200
1
27
44.5

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Sep 1, 2008
    Anticipated Study Completion Date :
    Dec 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00807274
      Other Study ID Numbers:
      • 06/Q0404/75
      First Posted:
      Dec 11, 2008
      Last Update Posted:
      Sep 25, 2009
      Last Verified:
      Sep 1, 2009

      Study Results

      No Results Posted as of Sep 25, 2009