Chronic Arterial Disease, Quality of Life and Mortality in Chronic Kidney Injury

Active, not recruiting

• Conditions: Kidney Diseases; Cardiovascular Diseases

• Registration Number: NCT04223726
• Lead Sponsor: Turku University Hospital

Brief Summary

CADKID-study is a prospective follow-up study assessing arterial disease, quality of life, mortality and their predictors in patients with severe chronic kidney disease.

Detailed Description

Chronic kidney disease (CKD) is associated with increased risk of cardiovascular disease and mortality as well as impaired quality of life. Participants of this study all have severe CKD, defined as estimated glomerular filtration rate \< 30 ml/min per 1.73 m\^2. Stress ergometry, echocardiography, ultrasound assessment of arterial intima-media thickness, lateral lumbar radiograph, ECG, laboratory tests and quality of life assessment were performed at the baseline of the study and will be repeated during follow-up. Atrial fibrillation and other cardiac arrhythmias as well as pulse wave velocity measurements will be explored. Diet diaries are gathered and analysed. The aim of the study is to identify factors associated with cardiovascular disease, quality of life and mortality in this cohort.

Study Timeline

• Study Start: 2013-08-22
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• estimated glomerular filtration rate < 30 ml/min per 1.73 m^2

Exclusion Criteria

• age under 18 years
• inability to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	5 years
Cardiovascular morbidity	5 years

Secondary Outcome Measures

Name	Time	Method
Changes in quality of life	2 years, 5 years	Kidney Disease Quality of Life Short Form (KDQOL-SF) instrument, consisting of 20 subscales (0-100), higher score indicating better quality of life
Rate of hospitalizations	2 years, 5 years
Carotid intima-media thickness	2 years, 5 years
Maximal bicycle stress ergometry performance	2 years, 5 years	Mean work load (watts) of the last 4 minutes of exercise, higher values indicating better performance
Femoral intima-media thickness	2 years, 5 years
Flow-mediated dilatation of brachial artery	2 years, 5 years	Dilatation at 60 seconds after the release of a cuff with pressure of 250 millimeters of mercury for 4.5 minutes, compared to at rest diameter
Cardiac diastolic function	2 years, 5 years	Echocardiography (ratio of the early to late ventricular filling velocities, ratio of transmitral Doppler early filling velocity to tissue Doppler early diastolic mitral annular velocity)
Number of participants with cardiac arrhythmias	2 years, 5 years
Abdominal aortic calcification (AAC) score	2 years, 5 years	Scale 0-24, higher values indicate more calcification
Left ventricular hypertrophy	2 years, 5 years	Echocardiography (Interventricular septum thickness, Posterior wall thickness, Left ventricular end-diastolic diameter, Left ventricular mass index)
Cardiac systolic function	2 years, 5 years	Echocardiography (Left ventricular ejection fraction, Left ventricular global longitudinal strain)

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland