MedDataX Logo

Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors

NCT ID: NCT01028703

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 arteries and heart.

Hypotheses. An isolated reduction in GFR occuring after surgical uni-nephrectomy is associated with long term adverse cardiac and vascular effects which include:

1. Increased arterial stiffness and left ventricular mass
2. Abnormalities in left ventricular systolic and diastolic function
3. Increased oxidative stress, inflammation and collagen turnover

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Donors

110 will be "cases" that undergo uninephrectomy

No interventions assigned to this group

Controls

110 "controls"

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Potential kidney donor attending University Hospital Birmingham NHS Foundation Trust

Exclusion Criteria

* Diabetes mellitus
* Atrial fibrillation
* Left ventricular dysfunction (ejection fraction \<40% on transthoracic echocardiography)
* History of cardiovascular or pulmonary disease
* Evidence of hypertensive end-organ damage.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

William E Moody

BHF Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan N Townend

Role: PRINCIPAL_INVESTIGATOR

Univeristy Hospital Birmingham NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Moody WE, Ferro CJ, Edwards NC, Chue CD, Lin EL, Taylor RJ, Cockwell P, Steeds RP, Townend JN; CRIB-Donor Study Investigators. Cardiovascular Effects of Unilateral Nephrectomy in Living Kidney Donors. Hypertension. 2016 Feb;67(2):368-77. doi: 10.1161/HYPERTENSIONAHA.115.06608.

Reference Type DERIVED
PMID: 26754643 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RKK3922

Identifier Type: -

Identifier Source: org_study_id