Atrial FibrillationNCT06330480
Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease
A study testing Intervention group in people with Atrial Fibrillation and Chronic Kidney Diseases, run by Prof. Dr. Folkert W. Asselbergs at 1 site in Netherlands.
Trial summary
The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Chronic Kidney Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 May 2025to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 50 and 75 years
- living in the selected regions (Breda, Utrecht, Arnhem, Eindhoven)
Who cannot join
- age <50 years or >75 years
- not living in the selected regions (Breda, Utrecht, Arnhem, Eindhoven)
- being institutionalized (e.g., subjects with intellectual disabilities or subjects living in nursing homes who have a limited life expectancy)
- participants of the previously conducted THOMAS Study (NL65228.042.18, METc 2018/687) will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population.
This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven). In total, a random sample of 160,000 people (aged 50-75 years) will be invited to participate in the study and another random sample of 160,000 people with the same characteristics will be included in the control group in which no screening will be offered.
Read more
The overall screening program will consist of three phases: a home-based testing phase, diagnostic screening phase, and a treatment phase:
- Phase 1: Subjects will be invited for a home-based screening that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation.
- Phase 2: Depending on the results on these home-based tests, subjects will be invited for further screening in a diagnostic screening facility. During this visit, physical data will be collected (height, weight, waist circumference, blood pressure, heart rhythm), blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that include questions on demographics, educational level, disease history, medication use, health literacy, and quality of life.
- Phase 3: Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines.
The primary study outcomes are:
Overall effectiveness of population based screening on atrial fibrillation and chronic kidney disease in subjects aged 50-75 years, based on:
- Participation rate of different screening strategies and phases;
- Yield of the screening (number of subjects with (newly) diagnosed disease and risk factors);
- Effectiveness of the atrial fibrillation screening, compared with standard care, based on the incidence of ischemic stroke);
- Effectiveness of the albuminuria screening, compared with standard care, based on the incidence of kidney failure events and Major Adverse Cardiovascular Events (MACE).
Read the detailed description
Background:
Currently, in the Netherlands there is no structured national approach for the early detection of cardiovascular disease, kidney disease, and type 2 diabetes in the general population, despite the social and economic impact of these disorders. Detecting these chronic conditions at an early stage could allow for adequate and early treatment to prevent the progression of these conditions and their complications, thereby reducing the societal and economic burden caused by these chronic diseases.
Objective of the study:
To investigate whether population-based screening of subjects aged 50-75 years can contribute to early detection and treatment of atrial fibrillation and chronic kidney disease (defined by elevated albuminuria), and thereby can contribute to prevention of the morbidity and mortality related to these diseases. This will be done by evaluating the participation rate, yield, and (cost-)effectiveness of the screening compared with standard care. Furthermore, the project aims to evaluate options for broader screening, including the early detection of heart failure, coronary artery disease, and type 2 diabetes.
Study design:
This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven).
Participants will be invited for a home-based screening (phase 1) that includes home-based testing; urine collection for detection of elevated albuminuria as indicator of chronic kidney disease, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation. Both home-based tests will be performed with CE-marked medical devices used according to their intended use. A subset of the population will also receive a short questionnaire. Depending on the results of the home-based tests, subjects might be invited for further screening in a diagnostic screening facility (phase 2). During this visit, physical data (height, weight, waist circumference, blood pressure, heart rhythm) will be collected, blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that includes questions on demographics, educational level, disease history, medication use, health literacy, and quality of life. Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines. It is planned that in a future protocol amendment an alternative treatment trajectory will be added in which participants may receive further treatment in the diagnostic screening facility.
Study population:
In total, a random sample of 160,000 people (aged 50-75 years) living in one of the four selected regions in the Netherlands will be invited to participate in the study. Another random sample of 160,000 people (aged 50-75 years) living in one of the four selected regions in the Netherlands will be included in the control group in which no screening will be offered.
- Being tested
- Intervention group
- Keywords
- Population-based screening
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
Subjects will be invited for a home-based screening (phase 1) that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement for detection of atrial fibrillation. Both home-based tests will be performed with CE-marked medical devices used according to their intended use. A subset of the population will also receive a short questionnaire. Depending on the results of the home-based tests, subjects might be invited for further screening in a diagnostic screening facility (phase 2), that includes collection of physical data, blood, and urine for the assessment of parameters that are indicative of cardiovascular disease, chronic kidney disease, diabetes type 2 or their risk factors. Participants will also receive a questionnaire. Based on the results of the diagnostic screening, participants may be referred to their GP for appropriate treatment according to the prevailing guidelines (phase 3)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | This group will be invited for the screening Receives: Other: Intervention group |
| Control group | No intervention | This group will not be invited for the screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate of the atrial fibrillation and albuminuria screening
- Participation rate of the home-based screening phase will be defined as the number of persons who completed the home-based screening phase relative to the number of persons invited in the corresponding arm (intention-to-screen);
- Participation rate of the diagnostic screening phase will be defined as the number of persons who completed the diagnostic screening phase relative to the number of persons invited for the diagnostic screening phase in the corresponding arm (in participants invited based on an 'abnormal' result in the home-based screening phase, i.e. either confirmed elevated albuminuria or an irregular heart rhythm);
- Participation rate of the treatment phase will be defined as the number of persons who completed the care initiation phase (i.e., number of participants visiting their GP; or - in future phases of the screening - the diagnostic center) relative to the number of persons referred for treatment in the corresponding arm (intention-to-screen).
Measured: 1 year after screening period
Yield of the atrial fibrillation and albuminuria screening
- Yield of home-based screening: number of participants tested positive (i.e., either confirmed positive urine test and/or abnormal heart rhythm test) relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited in the corresponding arm (intention-to-screen analysis);
- Yield of diagnostic screening: number of participants with (newly) diagnosed cardiovascular or chronic kidney disease, diabetes or risk factors, relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited in the corresponding arm (intention-to-screen analysis);
- Yield of treatment phase: number of participants completing the treatment phase relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited to the treatment phase in the corresponding arm (intention-to-screen analysis).
Measured: 1 year after screening period
Effectiveness of the atrial fibrillation screening
Effectiveness of the atrial fibrillation screening (the home-based screening program and follow-up strategy) will be based on the incidence of (fatal and non-fatal) ischemic stroke. This will be evaluated by comparing the event rates in the intervention group (the sample of 160,000 subjects invited for screening) and the control group (the sample of 160,000 subjects not invited for screening).
Measured: Up to 10 years follow-up after screening period
Effectiveness of the albuminuria screening
Effectiveness of the albuminuria screening (the home-based screening program and follow-up strategy), based on the incidence of the composite outcome of kidney failure events (defined as start of dialysis, receiving a kidney transplant, or death due to kidney failure without having started kidney function replacement treatment) and MACE (for albuminuria screening defined as cardiovascular mortality, stroke, and myocardial infarction, including CABG and PCI).
This will be evaluated by comparing the event rates in the population screened positive for elevated albuminuria and followed-up based on this result (i.e., participants in the standard strategy and other alternative strategies) and in the population screened positive for elevated albuminuria - at a later timepoint - and not followed-up based on this result (i.e., participants in 'alternative strategy B').
Measured: Up to 10 years follow-up after screening period
Secondary outcomes (5)
Effectiveness of the atrial fibrillation screening based on incidence of MACE events
Effectiveness of the atrial fibrillation screening (the home-based screening program and follow-up strategy), based on the incidence of MACE (for atrial fibrillation screening defined as cardiovascular mortality, stroke, non-hemorrhagic stroke, and myocardial infarction, including CABG and PCI).
This will be evaluated by comparing the event rates in the intervention group (the sample of 160,000 subjects invited for screening) and the control group (the sample of 160,000 subjects not invited for screening).
Measured: Up to 10 years follow-up after screening period
Effectiveness of the albuminuria screening based on incidence each individual MACE component
Effectiveness of the albuminuria screening (the home-based screening program and follow-up strategy), based on each individual component defining MACE (for albuminuria screening defined as cardiovascular mortality, stroke, and myocardial infarction, including CABG and PCI).
This will be evaluated by comparing the event rates in the in the population screened positive for elevated albuminuria and followed-up based on this result (i.e., participants in the standard strategy and other alternative strategies) and in the population screened positive for elevated albuminuria - at a later timepoint - and not followed-up based on this result (i.e., participants in 'alternative strategy B').
Measured: Up to 10 years follow-up after screening period
Safety of the atrial fibrillation screening
Safety of the atrial fibrillation screening (the home-based screening program and follow-up strategy), based on the incidence of the composite outcome of (fatal and non-fatal) hemorrhagic stroke, other major bleeding events leading to hospitalization (including but not limited to intracranial bleeds, sight-threatening eye bleeds, and serious gastrointestinal bleeding), and all cause-mortality.
This will be evaluated by comparing the event rates in the intervention group (the sample of 160,000 subjects invited for screening) and the control group (the sample of 160,000 subjects not invited for screening).
Measured: Up to 10 years follow-up after screening period
Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature.
An individual level simulation model will be developed to estimate the lifetime effects of the screening strategies for the detection of atrial fibrillation and chronic kidney disease by comparing the corresponding expected incidences of cardiovascular and chronic kidney disease, diabetes and their complications and endpoints with standard care. Incremental effectiveness will be calculated, expressed in QALYs gained for the different screening strategies. Costs will be calculated by multiplying resource use with the corresponding unit costs. The ICER between screening strategies and no screening, expressed in costs per QALY gained, will be calculated over a short-time (5-10 years after screening) and a lifetime time horizon. Finally, we will assess the chance that screening is cost-effective for a range of willingness-to-pay threshold values (range €20,000-€80,000 per QALY) and at which threshold for the screening costs screening would have a chance of ≥90% to be cost-effective.
Measured: Up to 10 years follow-up after screening period
Cost-effectiveness of screening strategies compared to standard of care: treatment effectiveness based on actual observed event rates
Using registry data, we will compare event rates between the intervention group (invited for screening) and the control group (not invited for screening) 5 and 10 years after the screening. Currently foreseen is that the data on fatal and non-fatal cardiovascular disease (according to the MACE criteria; based on corresponding ICD-10 codes) and renal events (dialysis and transplantation; based on corresponding ICD-10 codes) will be obtained and compared. These data will be obtained by linkage with CBS (i.e., Dutch Hospital Data, Vektis, Zorginstituut Nederland), Zorgverzekeraars Nederland, Pharmo, National Heart Registry, and general practitioner registries. These data will be input for the health economic simulation model, replacing earlier estimates of treatment effectiveness and treatment adherence. The ICER and estimation of the likelihood of screening being cost-effective will be repeated using this new and more accurate evidence.
Measured: Up to 10 years follow-up after screening period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start14 May 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Check@Home is a population-based screening with a phased assessment and implementation using an iterative design executed consecutively in four regions in the Netherlands.
- Masking
- None (open label)
- Enrolment
- 320,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Folkert W. Asselbergs
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cardiovascular Alliance, University Medical Center Groningen, Dutch Heart Foundation, Dutch Kidney Foundation, Dutch Diabetes Research Foundation, Maastricht University, AstraZeneca, UMC Utrecht, Radboud University Medical Center, Siemens Healthineers, University of Twente, Roche Diagnostics Nederland BV, Happitech BV, Stichting Radboud Universiteit, Stichting Netherlands Heart Institute, Topicus.Healthcare BV, Amsterdam UMC, location AMC
- Responsible party
- Sponsor-investigator, Prof. Dr. Folkert W. Asselbergs, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Prof. Dr. F. W. Asselbergs, Principal investigator, Amsterdam UMCProf. Dr. R. T. Gansevoort, Principal investigator, UMC Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330480
- Sponsor's protocol ID
- Check@Home
- Status last verified
- May 2025
- First submitted
- 7 Mar 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Mil D, Kieneker LM, Evers-Roeten B, Thelen MHM, de Vries H, Hemmelder MH, Dorgelo A, van Etten RW, Heerspink HJL, Gansevoort RT. Participation rate and yield of two home-based screening methods to detect increased albuminuria in the general population in the Netherlands (THOMAS): a prospective, randomised, open-label implementation study. Lancet. 2023 Sep 23;402(10407):1052-1064. doi: 10.1016/S0140-6736(23)00876-0. Epub 2023 Aug 16.
PubMed 37597522
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06330480
- Acronym / sponsor ID
- Check@Home
- Keywords
- Population-based screening
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320,000 participants (estimated)
- Lead sponsor
- Prof. Dr. Folkert W. AsselbergsUniversity, hospital or other
- Collaborators
- Dutch Cardiovascular Alliance, University Medical Center Groningen, Dutch Heart Foundation, Dutch Kidney Foundation, Dutch Diabetes Research Foundation, Maastricht University, AstraZeneca, UMC Utrecht, Radboud University Medical Center, Siemens Healthineers, University of Twente, Roche Diagnostics Nederland BV, Happitech BV, Stichting Radboud Universiteit, Stichting Netherlands Heart Institute, Topicus.Healthcare BV, Amsterdam UMC, location AMC
- Study start
- 14 May 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 26 Mar 2024 (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.
The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population.
This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven). In total, a random sample of 160,000 people (aged 50-75 years) will be invited to participate in the study and another random sample of 160,000 people with the same characteristics will be included in the control group in which no screening will be offered.
The overall screening program will consist of three phases: a home-based testing phase, diagnostic screening phase, and a treatment phase:
- Phase 1: Subjects will be invited for a home-based screening that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation.
- Phase 2: Depending on the results on these home-based tests, subjects will be invited for further screening in a diagnostic screening facility. During this visit, physical data will be collected (height, weight, waist circumference, blood pressure, heart rhythm), blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that include questions on demographics, educational level, disease history, medication use, health literacy, and quality of life.
- Phase 3: Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines.
The primary study outcomes are:
Overall effectiveness of population based screening on atrial fibrillation and chronic kidney disease in subjects aged 50-75 years, based on:
- Participation rate of different screening strategies and phases;
- Yield of the screening (number of subjects with (newly) diagnosed disease and risk factors);
- Effectiveness of the atrial fibrillation screening, compared with standard care, based on the incidence of ischemic stroke);
- Effectiveness of the albuminuria screening, compared with standard care, based on the incidence of kidney failure events and Major Adverse Cardiovascular Events (MACE).
Detailed description
Background:
Currently, in the Netherlands there is no structured national approach for the early detection of cardiovascular disease, kidney disease, and type 2 diabetes in the general population, despite the social and economic impact of these disorders. Detecting these chronic conditions at an early stage could allow for adequate and early treatment to prevent the progression of these conditions and their complications, thereby reducing the societal and economic burden caused by these chronic diseases.
Objective of the study:
To investigate whether population-based screening of subjects aged 50-75 years can contribute to early detection and treatment of atrial fibrillation and chronic kidney disease (defined by elevated albuminuria), and thereby can contribute to prevention of the morbidity and mortality related to these diseases. This will be done by evaluating the participation rate, yield, and (cost-)effectiveness of the screening compared with standard care. Furthermore, the project aims to evaluate options for broader screening, including the early detection of heart failure, coronary artery disease, and type 2 diabetes.
Study design:
This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven).
Participants will be invited for a home-based screening (phase 1) that includes home-based testing; urine collection for detection of elevated albuminuria as indicator of chronic kidney disease, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation. Both home-based tests will be performed with CE-marked medical devices used according to their intended use. A subset of the population will also receive a short questionnaire. Depending on the results of the home-based tests, subjects might be invited for further screening in a diagnostic screening facility (phase 2). During this visit, physical data (height, weight, waist circumference, blood pressure, heart rhythm) will be collected, blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that includes questions on demographics, educational level, disease history, medication use, health literacy, and quality of life. Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines. It is planned that in a future protocol amendment an alternative treatment trajectory will be added in which participants may receive further treatment in the diagnostic screening facility.
Study population:
In total, a random sample of 160,000 people (aged 50-75 years) living in one of the four selected regions in the Netherlands will be invited to participate in the study. Another random sample of 160,000 people (aged 50-75 years) living in one of the four selected regions in the Netherlands will be included in the control group in which no screening will be offered.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Check@Home is a population-based screening with a phased assessment and implementation using an iterative design executed consecutively in four regions in the Netherlands.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Intervention groupThis group will be invited for the screening |
| Control group | No intervention | –This group will not be invited for the screening |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 50 and 75 years
- living in the selected regions (Breda, Utrecht, Arnhem, Eindhoven)
Key exclusion criteria (4 listed)
- age <50 years or >75 years
- not living in the selected regions (Breda, Utrecht, Arnhem, Eindhoven)
- being institutionalized (e.g., subjects with intellectual disabilities or subjects living in nursing homes who have a limited life expectancy)
- participants of the previously conducted THOMAS Study (NL65228.042.18, METc 2018/687) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupSubjects will be invited for a home-based screening (phase 1) that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement for detection of atrial fibrillation. Both home-based tests will be performed with CE-marked medical devices used according to their intended use. A subset of the population will also receive a short questionnaire. Depending on the results of the home-based tests, subjects might be invited for further screening in a diagnostic screening facility (phase 2), that includes collection of physical data, blood, and urine for the assessment of parameters that are indicative of cardiovascular disease, chronic kidney disease, diabetes type 2 or their risk factors. Participants will also receive a questionnaire. Based on the results of the diagnostic screening, participants may be referred to their GP for appropriate treatment according to the prevailing guidelines (phase 3) | Other | Intervention group |
Primary outcome
Participation rate of the atrial fibrillation and albuminuria screening
Time frame: 1 year after screening period
* Participation rate of the home-based screening phase will be defined as the number of persons who completed the home-based screening phase relative to the number of persons invited in the corresponding arm (intention-to-screen); * Participation rate of the diagnostic screening phase will be defined as the number of persons who completed the diagnostic screening phase relative to the number of persons invited for the diagnostic screening phase in the corresponding arm (in participants invited based on an 'abnormal' result in the home-based screening phase, i.e. either confirmed elevated albuminuria or an irregular heart rhythm); * Participation rate of the treatment phase will be defined as the number of persons who completed the care initiation phase (i.e., number of participants visiting their GP; or - in future phases of the screening - the diagnostic center) relative to the number of persons referred for treatment in the corresponding arm (intention-to-screen).
Yield of the atrial fibrillation and albuminuria screening
Time frame: 1 year after screening period
* Yield of home-based screening: number of participants tested positive (i.e., either confirmed positive urine test and/or abnormal heart rhythm test) relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited in the corresponding arm (intention-to-screen analysis); * Yield of diagnostic screening: number of participants with (newly) diagnosed cardiovascular or chronic kidney disease, diabetes or risk factors, relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited in the corresponding arm (intention-to-screen analysis); * Yield of treatment phase: number of participants completing the treatment phase relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited to the treatment phase in the corresponding arm (intention-to-screen analysis).
Effectiveness of the atrial fibrillation screening
Time frame: Up to 10 years follow-up after screening period
Effectiveness of the atrial fibrillation screening (the home-based screening program and follow-up strategy) will be based on the incidence of (fatal and non-fatal) ischemic stroke. This will be evaluated by comparing the event rates in the intervention group (the sample of 160,000 subjects invited for screening) and the control group (the sample of 160,000 subjects not invited for screening).
Effectiveness of the albuminuria screening
Time frame: Up to 10 years follow-up after screening period
Effectiveness of the albuminuria screening (the home-based screening program and follow-up strategy), based on the incidence of the composite outcome of kidney failure events (defined as start of dialysis, receiving a kidney transplant, or death due to kidney failure without having started kidney function replacement treatment) and MACE (for albuminuria screening defined as cardiovascular mortality, stroke, and myocardial infarction, including CABG and PCI). This will be evaluated by comparing the event rates in the population screened positive for elevated albuminuria and followed-up based on this result (i.e., participants in the standard strategy and other alternative strategies) and in the population screened positive for elevated albuminuria - at a later timepoint - and not followed-up based on this result (i.e., participants in 'alternative strategy B').
5 secondary outcomes
Effectiveness of the atrial fibrillation screening based on incidence of MACE events
Time frame: Up to 10 years follow-up after screening period
Effectiveness of the albuminuria screening based on incidence each individual MACE component
Time frame: Up to 10 years follow-up after screening period
Safety of the atrial fibrillation screening
Time frame: Up to 10 years follow-up after screening period
Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature.
Time frame: Up to 10 years follow-up after screening period
Cost-effectiveness of screening strategies compared to standard of care: treatment effectiveness based on actual observed event rates
Time frame: Up to 10 years follow-up after screening period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 37597522van Mil D, Kieneker LM, Evers-Roeten B, Thelen MHM, de Vries H, Hemmelder MH, Dorgelo A, van Etten RW, Heerspink HJL, Gansevoort RT. Participation rate and yield of two home-based screening methods to detect increased albuminuria in the general population in the Netherlands (THOMAS): a prospective, randomised, open-label implementation study. Lancet. 2023 Sep 23;402(10407):1052-1064. doi: 10.1016/S0140-6736(23)00876-0. Epub 2023 Aug 16.
- Related InfoLink provided by the sponsor.
- 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.
Prof. Dr. F. W. Asselbergs principal investigator
Amsterdam UMC
Prof. Dr. R. T. Gansevoort principal investigator
UMC Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Atrial Fibrillation and Chronic Kidney Diseases, run by Prof. Dr. Folkert W. Asselbergs at 1 site in Netherlands.
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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 16 May 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Participation rate of the atrial fibrillation and albuminuria screening (time frame: 1 year after screening period). The study lists 4 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 NCT06330480, which also lists 1 linked publication.
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 16 May 2025.