Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease

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.

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).

Conditions

• Atrial Fibrillation
• Chronic Kidney Diseases
• Diabetes Mellitus, Type 2

Interventions

OTHER

Intervention group

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)

Sponsors & Collaborators

• Dutch Cardiovascular Alliance

  collaborator UNKNOWN

• University Medical Center Groningen

  collaborator OTHER

• Dutch Heart Foundation

  collaborator OTHER

• Dutch Kidney Foundation

  collaborator OTHER

• Dutch Diabetes Research Foundation

  collaborator OTHER

• Maastricht University

  collaborator OTHER

• AstraZeneca

  collaborator INDUSTRY

• UMC Utrecht

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Siemens Healthineers Nederland BV

  collaborator UNKNOWN

• University of Twente

  collaborator OTHER

• Roche Diagnostics Nederland BV

  collaborator UNKNOWN

• Happitech BV

  collaborator UNKNOWN

• Stichting Radboud Universiteit

  collaborator UNKNOWN

• Stichting Netherlands Heart Institute

  collaborator UNKNOWN

• Topicus.Healthcare BV

  collaborator UNKNOWN

• Amsterdam UMC, location AMC

  collaborator OTHER

• Prof. Dr. Folkert W. Asselbergs

  lead OTHER

Principal Investigators

• Prof. Dr. F. W. Asselbergs · Amsterdam UMC

• Prof. Dr. R. T. Gansevoort · UMC Groningen

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-14

Primary Completion

2028-06-01

Completion

2028-11-01

Countries

• Netherlands

Study Locations