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NCT01008306 Clinical Trial

Cardiovascular Risk Factors After Renal Transplantation in Children and Adults

Hypertension Clinical Trial

— HENT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01008306
Other study ID # S-07245b
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 3, 2009
Last updated November 4, 2009
Start date June 2007

Study information
Verified date November 2009
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 38 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital Rikshospitalet HF, Division of Pediatrics Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital Norwegian Red Cross

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Secondary other cardiovascular risk factors 2007-2010 No
Secondary hypertension 2007-2010 No
Secondary impaired glucose intolerance 2007-2010 No
Secondary left ventricular hypertrophy, 2007-2010 No
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