An Investigation Into the Cardiovascular Risk and Aetiology of CKDu in Sri Lanka

Summary

1. We hypothesise that CKDu patients will have increased arterial stiffness and thus increased all-cause and cardiovascular mortality. The first objective of this study is to recruit a cohort of \~ 50 CKDu patients who attend the CKDu clinic in Anuradhapura, and measure their arterial stiffness using the TensioMed® Arteriograph™ (details below). We will recruit an age, sex and blood pressure matched control group of healthy Sri Lankans (consenting visitors with patients both to clinic and as inpatients), and if possible, a second control group, similarly age, sex and blood pressure matched, who have CKD of known causes and attend general renal clinic in Anuradhapura.
2. We hypothesise that detailed renal analysis will give insight into the aetiology of CKDu in the North Central Province of Sri Lanka. The second objective of the study is to recruit up to 250 CKDu patients and to characterize their disease profile using analysis serum and urine renal biomarkers, exosomes, proteomics and DNA adducts.

Conditions

• CKDu
• Arterial Stiffness
• Proteinuria
• Serum Creatinine
• Urinary Biomarkers
• DNA Adducts

Interventions

DEVICE

Arterial Stiffness Assessment

The following will be measured: brachial systolic and diastolic bp, heart rate, mean arterial bp, pulse pressure, brachial augmentation index (difference between the amplitudes of the late (backward) systolic wave (P2) and the early (forward) systolic wave (P1) over the pulse pressure x 100), central augmentation, ejection duration of the left ventricle, return time (time of the pulse wave travelling from aortic root to the bifurcation and back), aortic pulse wave velocity ( velocity of the pulse wave in the aorta), central systolic bp, central pulse pressure and diastolic reflection area (provides information about the quality of diastolic filling in the coronary arteries). We will perform an arterial age assessment. Patients are given a feedback form with their results to give to their general. Those with increased arterial stiffness will be tested for serum calcium and phosphate levels, and audited to ensure that a statin is commenced if not contraindicated.

Sponsors & Collaborators

• Rajarata University, Sri Lanka

  collaborator OTHER

• University of Edinburgh

  lead OTHER

Principal Investigators

• Michael Eddleston, MA PhD FRCPEdin · University of Edinburgh

• Neeraj Dhaun, PhD MRCP · University of Edinburgh

• Sisira Siribaddana, MD FCCP · Rajarata University, Sri Lanka

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2017-05-01

Completion

2017-05-01

Countries

• Sri Lanka

Study Locations