Clinical trial NCT04223726: Chronic Arterial Disease, Quality of Life and Mortality in Chronic Kidney Injury
Official title: Chronic Arterial Disease, Quality of Life and Mortality in Chronic Kidney Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Diseases
Cardiovascular Diseases
Keywords: chronic kidney disease
quality of life
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-10
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Predialysis outpatient clinic in Turku University Hospital Kidney Center

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Cardiovascular morbidity
timeFrame: 5 years
Secondary outcomes:
measure: Changes in quality of life
timeFrame: 2 years, 5 years
measure: Number of participants with cardiac arrhythmias
timeFrame: 2 years, 5 years
measure: Rate of hospitalizations
timeFrame: 2 years, 5 years
measure: Abdominal aortic calcification (AAC) score
timeFrame: 2 years, 5 years
measure: Carotid intima-media thickness
timeFrame: 2 years, 5 years
measure: Femoral intima-media thickness
timeFrame: 2 years, 5 years
measure: Flow-mediated dilatation of brachial artery
timeFrame: 2 years, 5 years
measure: Maximal bicycle stress ergometry performance
timeFrame: 2 years, 5 years
measure: Left ventricular hypertrophy
timeFrame: 2 years, 5 years
measure: Cardiac systolic function
timeFrame: 2 years, 5 years
measure: Cardiac diastolic function
timeFrame: 2 years, 5 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital Kidney Center
name: Kaj Metsärinne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital Intensive Care Unit
name: Mikko J Järvisalo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lankinen R, Hakamaki M, Metsarinne K, Koivuviita N, Parkka JP, Saarenhovi M, Hellman T, Jarvisalo MJ. Association of maximal stress ergometry performance with troponin T and abdominal aortic calcification score in advanced chronic kidney disease. BMC Nephrol. 2021 Feb 4;22(1):50. doi: 10.1186/s12882-021-02251-y.