NCT06330480Enrolling by invitation
Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 320000 (estimated)
- First submitted
- 7 Mar 2024
- Start date
- 14 May 2025
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Prof. Dr. Folkert W. Asselbergs
- NCT number
- NCT06330480
What you commit to
- Study type: Interventional
- Planned participants: 320000
- From 14 May 2025 to the primary completion date, 1 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- participants of the previously conducted THOMAS Study (NL65228.042.18, METc 2018/687) will be excluded.
Age
- age \<50 years or \>75 years
Other
- 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)
Who the study is looking for
- aged between 50 and 75 years
- living in the selected regions (Breda, Utrecht, Arnhem, Eindhoven)
Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stichting Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.