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

Sponsor
Turku University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04223726
Collaborator
(none)
210
1
124.3
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    210 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Chronic Arterial Disease, Quality of Life and Mortality in Chronic Kidney Injury
    Actual Study Start Date :
    Aug 22, 2013
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [5 years]

    2. Cardiovascular morbidity [5 years]

    Secondary Outcome Measures

    1. 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

    2. Number of participants with cardiac arrhythmias [2 years, 5 years]

    3. Rate of hospitalizations [2 years, 5 years]

    4. Abdominal aortic calcification (AAC) score [2 years, 5 years]

      Scale 0-24, higher values indicate more calcification

    5. Carotid intima-media thickness [2 years, 5 years]

    6. Femoral intima-media thickness [2 years, 5 years]

    7. 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

    8. 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

    9. Left ventricular hypertrophy [2 years, 5 years]

      Echocardiography (Interventricular septum thickness, Posterior wall thickness, Left ventricular end-diastolic diameter, Left ventricular mass index)

    10. Cardiac systolic function [2 years, 5 years]

      Echocardiography (Left ventricular ejection fraction, Left ventricular global longitudinal strain)

    11. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turku University Hospital Turku Finland

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turku University Hospital
    ClinicalTrials.gov Identifier:
    NCT04223726
    Other Study ID Numbers:
    • T41/2013
    First Posted:
    Jan 10, 2020
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Turku University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2021