NCT01769924

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

January 8, 2013

Last Update Submit

February 22, 2022

Conditions

Living Kidney Donors

Keywords

Kidney donorsArterial stiffnessBlood pressureNephrectomy

Outcome Measures

Primary Outcomes (1)

  • Aortic Pulse Wave Velocity (aPWV) adjusted for mean arterial pressure and heart rate

    12 months

Secondary Outcomes (7)

  • Clinic blood pressure

    12 months

  • Number of patients newly diagnosed with hypertension

    12 months

  • Augmentation index (AIx)

    12 months

  • Central blood pressure

    12 months

  • N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Live kidney donors

Nephrectomy

Other: Nephrectomy

Healthy controls

Who also meet criteria to donate a kidney

Interventions

NephrectomyOTHER

Nephrectomy for the purposes of living kidney donation

Live kidney donors

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Birmingham NHS Foundation Trust

Birmingham, B17 0HT, United Kingdom

Location

Related Publications (2)

  • Moody WE, Tomlinson LA, Ferro CJ, Steeds RP, Mark PB, Zehnder D, Tomson CR, Cockcroft JR, Wilkinson IB, Townend JN. Effect of A Reduction in glomerular filtration rate after NEphrectomy on arterial STiffness and central hemodynamics: rationale and design of the EARNEST study. Am Heart J. 2014 Feb;167(2):141-149.e2. doi: 10.1016/j.ahj.2013.10.024. Epub 2013 Nov 6.

    PMID: 24439974BACKGROUND

  • Price AM, Greenhall GHB, Moody WE, Steeds RP, Mark PB, Edwards NC, Hayer MK, Pickup LC, Radhakrishnan A, Law JP, Banerjee D, Campbell T, Tomson CRV, Cockcroft JR, Shrestha B, Wilkinson IB, Tomlinson LA, Ferro CJ, Townend JN; EARNEST investigators. Changes in Blood Pressure and Arterial Hemodynamics following Living Kidney Donation. Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1330-1339. doi: 10.2215/CJN.15651219. Epub 2020 Aug 25.

    PMID: 32843374DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine, serum and plasma.

MeSH Terms

Interventions

Nephrectomy

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • John Cockcroft, PhD

    Cardiff

    STUDY CHAIR

  • Ian B Wilkinson

    Cambridge Heart Inc.

    STUDY DIRECTOR

  • Jonathan N Townend

    Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist and Honorary Reader in Cardiology

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 17, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2016

Study Completion

March 1, 2017

Last Updated

February 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)