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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Kidney Diseases

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 Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Predialysis outpatient clinic in Turku University Hospital Kidney Center

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	5 years
Cardiovascular morbidity	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life	Kidney Disease Quality of Life Short Form (KDQOL-SF) instrument, consisting of 20 subscales (0-100), higher score indicating better quality of life	2 years, 5 years
Number of participants with cardiac arrhythmias		2 years, 5 years
Rate of hospitalizations		2 years, 5 years
Abdominal aortic calcification (AAC) score	Scale 0-24, higher values indicate more calcification	2 years, 5 years
Carotid intima-media thickness		2 years, 5 years
Femoral intima-media thickness		2 years, 5 years
Flow-mediated dilatation of brachial artery	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	2 years, 5 years
Maximal bicycle stress ergometry performance	Mean work load (watts) of the last 4 minutes of exercise, higher values indicating better performance	2 years, 5 years
Left ventricular hypertrophy	Echocardiography (Interventricular septum thickness, Posterior wall thickness, Left ventricular end-diastolic diameter, Left ventricular mass index)	2 years, 5 years
Cardiac systolic function	Echocardiography (Left ventricular ejection fraction, Left ventricular global longitudinal strain)	2 years, 5 years
Cardiac diastolic function	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)	2 years, 5 years

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Kaj Metsärinne, MD, PhD, Turku University Hospital Kidney Center; Principal Investigator: Mikko J Järvisalo, MD, PhD, Turku University Hospital Intensive Care Unit

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2013
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; chronic kidney disease
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Diseases; Kidney Diseases
• Other Study ID Numbers: T41/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No