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

Cardiovascular Diseases Clinical Trial

— CADKID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04223726
• Other study ID #: T41/2013
• Status: Active, not recruiting
• Start date: August 22, 2013
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Kidney Diseases

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		5 years
Primary	Cardiovascular morbidity		5 years
Secondary	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
Secondary	Number of participants with cardiac arrhythmias		2 years, 5 years
Secondary	Rate of hospitalizations		2 years, 5 years
Secondary	Abdominal aortic calcification (AAC) score	Scale 0-24, higher values indicate more calcification	2 years, 5 years
Secondary	Carotid intima-media thickness		2 years, 5 years
Secondary	Femoral intima-media thickness		2 years, 5 years
Secondary	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
Secondary	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
Secondary	Left ventricular hypertrophy	Echocardiography (Interventricular septum thickness, Posterior wall thickness, Left ventricular end-diastolic diameter, Left ventricular mass index)	2 years, 5 years
Secondary	Cardiac systolic function	Echocardiography (Left ventricular ejection fraction, Left ventricular global longitudinal strain)	2 years, 5 years
Secondary	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