ongitudinal change and cardiovascular (CV) impact of blood pressure adjusted pulse wave velocity in patients with advanced chronic kidney disease

Conditions: I70.9
N18.3
N18.4
N18.5
Generalized and unspecified atherosclerosis
Chronic kidney disease, stage 3
Chronic kidney disease, stage 4
Chronic kidney disease, stage 5

Registration Number: DRKS00016291

Lead Sponsor: Charité Universitätsmedizin Berlin Campus Benjamin Franklin Klinik für Nephrologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 400

Inclusion Criteria

• Presence of advanced chronic kidney disease (CKD) defined as estimated glomerular filtration rate (eGFR) <45 ml/min/1,73 m2 according to creatinine-based CKD-EPI formula or patients on dialysis
• At least one valid long-term BP-recording and pulse wave analysis (at least 20 hours or at least 38 hours for the study participants on dialysis with at least 70% valid measurements);
• Subjects willing and able to provide informed consent;
• Dialysis patients must be at least one year on dialysis;
• Assumed life expectancy at least one year

Exclusion Criteria

• Arrhythmias, which make oscillometrical BP-measurement or pulse wave analysis impossible;
• Age<18 years;
• Stenosis located proximately to or at the measurement point;
• Myocardial infarction, stroke or invasive CV intervention in the last three months;
• Subject not able or willing to give informed consent;
• Hospital stay in last four weeks

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of cardiovascular events after 24 months in association with blood pressure adjusted PWV (Pulse wave velocity):<br>The PWV will be adjusted to the 120 mmHg central blood pressure (PWV120). Afterwards, quartiles of PWV120 will be made and the incidence of cardiovascular events in the quartiles will be observed during follow-up

Secondary Outcome Measures

Name	Time	Method
1. Trajectories of longitudinal change in blood pressure adjusted PWV during follow up<br>2. At least 0.5 m/s higher PWV120cSBP in study patients compared with subjects from extern collective with moderate cardiovascular risk