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OpenTrials
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NCT Number: NCT01028703

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Potential kidney donor attending University Hospital Birmingham NHS Foundation Trust

Current nationally set 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.

Treatment and study plan

Primary outcomes

  1. Left ventricular mass as measured by CMR and Echocardiography

    Time frame: 3 years

  2. Arterial stiffness as measured by pulse wave velocity

    Time frame: 3 years

Secondary outcomes

  1. Aortic compliance measured by cardiac magnetic resonance imaging

    Time frame: 3 years

  2. Left ventricular systolic and diastolic elastance measured by echocardiography;

    Time frame: 3 years

  3. 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).

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Registry information

Official study title

Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2009
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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