A Prospective UK Multicentre Study of Kidney Donors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Cambridge University Hospitals NHS Foundation Trust
Sponsor:
Collaborators:
British Heart Foundation
University Hospital Birmingham NHS Foundation Trust
North Bristol NHS Trust
University Hospitals Coventry and Warwickshire NHS Trust
Kings Health Partners
Glasgow Western Infirmary
Belfast City Hospital
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Jonathan N. Townend, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01769924
First received: January 8, 2013
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the cardiovascular system.


Condition Intervention
Living Kidney Donors
Other: Nephrectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of A Reduction in Glomerular Filtration Rate After Nephrectomy on Arterial Stiffness (EARNEST)

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Aortic Pulse Wave Velocity (aPWV) adjusted for mean arterial pressure and heart rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 24 hour ambulatory systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of patients newly diagnosed with hypertension [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    As defined by commencement of antihypertensive therapy

  • Augmentation index (AIx) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Central blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Central haemodynamics

  • N-terminal prohormone of brain natriuretic peptide (NT-proBNP) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Urinary albumin: creatinine ratio (ACR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Urine, serum and plasma.


Estimated Enrollment: 880
Study Start Date: February 2013
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Live kidney donors
Nephrectomy
Other: Nephrectomy
Healthy controls
Nil

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • A donor group will be recruited from all patients undergoing donor nephrectomy.
  • A contemporaneous control group will be recruited from clinics, advertisements within and outside the institutions and from any local volunteer databases.

Exclusion Criteria:

  • These will be the same for donors and controls. The current nationally set exclusion criteria for donors include age/glomerular filtration rate (GFR) cutoff, diabetes mellitus, any history of cardiovascular or pulmonary disease, evidence of hypertensive end-organ damage, known left ventricular dysfunction (including ejection fraction < 40%) and atrial fibrillation.
  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: NCT01769924

Contacts
Contact: Jonathan N Townend john.townend@uhb.nhs.uk
Contact: William E Moody william.moody@nhs.net

Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
British Heart Foundation
University Hospital Birmingham NHS Foundation Trust
North Bristol NHS Trust
University Hospitals Coventry and Warwickshire NHS Trust
Kings Health Partners
Glasgow Western Infirmary
Belfast City Hospital
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Study Chair: John Cockcroft, PhD Cardiff
Study Director: Ian B Wilkinson Cambridge Heart Inc.
Principal Investigator: Jonathan N Townend Birmingham
  More Information

No publications provided by Cambridge University Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan N. Townend, Consultant Cardiologist and Honorary Reader in Cardiology, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01769924     History of Changes
Other Study ID Numbers: A092761
Study First Received: January 8, 2013
Last Updated: January 15, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
kidney donors
arterial stiffness
blood pressure

ClinicalTrials.gov processed this record on July 20, 2014