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

NCT01028703 | Completed DMC

• 1 other identifier: RKK3922
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; left ventricular dysfunction; diastolic dysfunction; hypertension

Outcome Measures

Primary Outcomes (2)

• Left ventricular mass as measured by CMR and Echocardiography

  3 years

• Arterial stiffness as measured by pulse wave velocity

  3 years

Secondary Outcomes (3)

• Aortic compliance measured by cardiac magnetic resonance imaging

  3 years

• Left ventricular systolic and diastolic elastance measured by echocardiography;

  3 years

• Oxidative stress, inflammation and collagen turnover measured by blood assays of plasma renin, aldosterone, high sensitivity C-reactive protein (hsCRP), procollagen type III aminoterminal peptide (PIIINP) and C-telopeptide for type I collagen (CITP).

  3 years

Study Arms (2)

Donors

110 will be "cases" that undergo uninephrectomy

Controls

110 "controls"

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Renal outpatient clinic

You may qualify if:

• Potential kidney donor attending University Hospital Birmingham NHS Foundation Trust

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Sites (1)

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26754643 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Ventricular Dysfunction, Left; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jonathan N Townend

  Univeristy Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BHF Clinical Research Fellow

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: September 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

GB (1)