Cardiovascular Risk Factors After Renal Transplantation in Children and Adults (HENT)

November 4, 2009 updated by: Oslo University Hospital

Outcome After Pediatric Renal Transplantation: Cardiorespiratory Fitness, Cardiovascular Risk Factors and Quality of Life

Renal transplantation of children started in Norway in 1970.Since the beginning, >80% of renal transplants are provided from Living Donors(mainly parents), short pre-transplant dialysis time( median 4 months) and 50% of transplantations are performed before dialysis is needed.This gives good premises for graft survival and avoidance of detrimental effects of dialysis. However, renal transplanted children are subjected to an increased cardiovascular morbidity and mortality in adulthood due to consequences of chronic renal failure and immunosuppressive treatment.Cardiovascular death comprises 30-40% of death causes. In this cross-sectional study we evaluate cardiovascular risk factors in childhood- and also in young adults renal transplanted in childhood.

Focus is cardiorespiratory fitness using treadmill testing,24h BP measurements, anthropometrics including waist circumference,echocardiography,intima media thickness of carotids, glucose intolerance test.Participants are also requested to fill out physical activity recalls and Quality of life questionnaires.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Oslo University Hospital Rikshospitalet HF, Division of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal transplanted children, adolescents and young adults transplanted in the period 1983-2006 in the same center (Oslo University Hospital, Rikshospitalet)

Description

Inclusion Criteria:

  • Transplanted after 1983, functioning graft

Exclusion Criteria:

  • Patients in dialysis
  • In part of the study concerning treadmill testing: Age<8 years, orthopedic limitations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Renal transplanted children and young adults

Renal transplanted children and adolescents (2-18yrs) transplanted between 1993-2006.

Renal transplanted young adults aged 20-35 yrs old, transplanted from 1983 onwards.

What is the study measuring?

Secondary Outcome Measures

Outcome Measure
Time Frame
other cardiovascular risk factors
Time Frame: 2007-2010
2007-2010
hypertension
Time Frame: 2007-2010
2007-2010
impaired glucose intolerance
Time Frame: 2007-2010
2007-2010
left ventricular hypertrophy,
Time Frame: 2007-2010
2007-2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Norwegian Red Cross

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 4, 2009

First Posted (Estimate)

November 5, 2009

Study Record Updates

Last Update Posted (Estimate)

November 5, 2009

Last Update Submitted That Met QC Criteria

November 4, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-07245b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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