Kidney DiseasesCADKIDNCT04223726
Chronic Arterial Disease, Quality of Life and Mortality in Chronic Kidney Injury
An observational study of Kidney Diseases and Cardiovascular Diseases, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Cardiovascular Diseases
- How many people
- 210 participants
- Where
- 1 siteFinland
- Study dates
- 22 Aug 2013to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the Predialysis outpatient clinic in Turku University Hospital Kidney Center
Who may be able to join
- estimated glomerular filtration rate < 30 ml/min per 1.73 m^2
Who cannot join
- age under 18 years
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Kidney Diseases, Cardiovascular Diseases
- Keywords
- chronic kidney disease, quality of life
- Medical subject headings
- Kidney Diseases, Cardiovascular Diseases, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 5 years
Cardiovascular morbidity
Measured: 5 years
Secondary outcomes (11)
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
Measured: 2 years, 5 years
Number of participants with cardiac arrhythmias
Measured: 2 years, 5 years
Rate of hospitalizations
Measured: 2 years, 5 years
Abdominal aortic calcification (AAC) score
Scale 0-24, higher values indicate more calcification
Measured: 2 years, 5 years
Carotid intima-media thickness
Measured: 2 years, 5 years
Femoral intima-media thickness
Measured: 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
Measured: 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
Measured: 2 years, 5 years
Left ventricular hypertrophy
Echocardiography (Interventricular septum thickness, Posterior wall thickness, Left ventricular end-diastolic diameter, Left ventricular mass index)
Measured: 2 years, 5 years
Cardiac systolic function
Echocardiography (Left ventricular ejection fraction, Left ventricular global longitudinal strain)
Measured: 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)
Measured: 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start22 Aug 2013
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kaj Metsärinne, MD, PhD, Principal investigator, Turku University Hospital Kidney CenterMikko J Järvisalo, MD, PhD, Principal investigator, Turku University Hospital Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223726
- Sponsor's protocol ID
- T41/2013
- Acronym
- CADKID
- Status last verified
- Apr 2024
- First submitted
- 10 Dec 2019
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salonen S, Kaipainen E, Hakamaki M, Liuhto N, Manni N, Toukola T, Virtanen J, Lankinen R, Metsarinne K, Vasankari T, Airaksinen KEJ, Jarvisalo MJ, Wittfooth S, Hellman T. Association of long cardiac troponin T forms with adverse long-term outcomes in patients with advanced chronic kidney disease. BMC Nephrol. 2026 Feb 6;27(1):159. doi: 10.1186/s12882-026-04803-6.
PubMed 41652572Lankinen 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.
PubMed 33541279
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Arterial Disease, Quality of Life and Mortality in Chronic Kidney Injury
- ClinicalTrials.gov ID
- NCT04223726
- Acronym / sponsor ID
- CADKID / T41/2013
- Conditions
- Kidney Diseases, Cardiovascular Diseases
- Keywords
- chronic kidney disease, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 22 Aug 2013 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the Predialysis outpatient clinic in Turku University Hospital Kidney Center
Key inclusion criteria (1 listed)
- estimated glomerular filtration rate < 30 ml/min per 1.73 m^2
Key exclusion criteria (2 listed)
- age under 18 years
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 5 years
Cardiovascular morbidity
Time frame: 5 years
11 secondary outcomes
Changes in quality of life
Time frame: 2 years, 5 years
Number of participants with cardiac arrhythmias
Time frame: 2 years, 5 years
Rate of hospitalizations
Time frame: 2 years, 5 years
Abdominal aortic calcification (AAC) score
Time frame: 2 years, 5 years
Carotid intima-media thickness
Time frame: 2 years, 5 years
Femoral intima-media thickness
Time frame: 2 years, 5 years
Flow-mediated dilatation of brachial artery
Time frame: 2 years, 5 years
Maximal bicycle stress ergometry performance
Time frame: 2 years, 5 years
Left ventricular hypertrophy
Time frame: 2 years, 5 years
Cardiac systolic function
Time frame: 2 years, 5 years
Cardiac diastolic function
Time frame: 2 years, 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 41652572Salonen S, Kaipainen E, Hakamaki M, Liuhto N, Manni N, Toukola T, Virtanen J, Lankinen R, Metsarinne K, Vasankari T, Airaksinen KEJ, Jarvisalo MJ, Wittfooth S, Hellman T. Association of long cardiac troponin T forms with adverse long-term outcomes in patients with advanced chronic kidney disease. BMC Nephrol. 2026 Feb 6;27(1):159. doi: 10.1186/s12882-026-04803-6.
- Derived from this study: PubMed 33541279Lankinen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaj Metsärinne, MD, PhD principal investigator
Turku University Hospital Kidney Center
Mikko J Järvisalo, MD, PhD principal investigator
Turku University Hospital Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases and Cardiovascular Diseases, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.