Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-01 @ 11:19 AM
Study NCT ID:
NCT01028703
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors
Sponsor:
University Hospital Birmingham NHS Foundation Trust
Organization:
Study Overview
Official Title:
Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: