Cardiovascular DiseasesU-SCREENNCT07614659
Uppsala Self-Screening of Cardiovascular Health
A study testing Home-based multimodal cardiovascular screening in people with Cardiovascular Diseases and Hypertension, run by Johan Sundström at 1 site in Sweden.
Trial summary
U-SCREEN is a randomized controlled trial evaluating whether systematic home-based multimodal screening for cardiovascular risk conditions, offered to residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years of age, can identify clinically actionable cardiovascular risk factors more effectively than usual… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Dyslipidemias
- What is being tested?
- Home-based multimodal cardiovascular screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2025to Dec 2037
- 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
- Resident in Region Uppsala, Sweden
- Turning 50, 55, 60, 65, 70 or 75 years during recruitment period
- Able to provide informed consent
Who cannot join
- Inability to provide informed consent
- Protected identity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, 751 85
Sundström, +46 70 422 52 20, johan.sundstrom@uu.se
Sundström
About this study
Official title: Uppsala Self-Screening of Cardiovascular Health: A Randomized Controlled Trial of Home-Based Multimodal Cardiovascular Screening Versus Usual Care in Middle-Aged and Older Adults
U-SCREEN is a randomized controlled trial evaluating whether systematic home-based multimodal screening for cardiovascular risk conditions, offered to residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years of age, can identify clinically actionable cardiovascular risk factors more effectively than usual care. Participants randomized to the screening arm receive a home blood pressure measurement device, a dried blood spot sampling kit (for ApoB, HbA1c and creatinine), and a digital questionnaire. The control arm receives usual care. Recruitment runs 2024-2027 with a target identification of 10,000 cardiovascular risk conditions.
Read the detailed description
BACKGROUND Cardiovascular disease remains the leading cause of death and disability in Sweden and globally. Hypertension, dyslipidemia, diabetes, atrial fibrillation, and chronic kidney disease are largely asymptomatic but treatable conditions for which effective preventive interventions exist. Despite this, a substantial proportion of affected individuals are undiagnosed or untreated. Population-based screening at clinics is resource-intensive and reaches only a fraction of those at risk. Digital tools and home-based self-sampling now make it feasible to scale cardiovascular screening to whole populations at limited marginal cost.
OBJECTIVES To determine whether a home-based multimodal cardiovascular screening program identifies more cardiovascular risk conditions than usual care in middle-aged and older adults. To evaluate the impact of screening on initiation of evidence-based preventive treatment; on cardiovascular events; on healthcare utilization and costs; and on participant-reported outcomes including health-related quality of life.
DESIGN Pragmatic, register-based, two-arm parallel-group randomized controlled trial. Eligible residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years during the recruitment period are invited and, after digital informed consent, randomized 1:1 to the screening arm or the control arm.
INTERVENTION (SCREENING ARM)
Participants receive a home package containing:
- A validated automated upper-arm blood pressure monitor with instructions for a 7-day home measurement schedule;
- A dried blood spot sampling kit for self-collection and mail-back analysis of ApoB, HbA1c, and creatinine;
- A digital questionnaire on lifestyle, symptoms, family history, and existing diagnoses and medications.
Results are returned to the participant via a digital portal together with structured advice; participants with findings exceeding pre-specified thresholds receive guideline-directed pharmacotherapy and are referred for clinical follow-up in routine care.
COMPARATOR (CONTROL ARM) Usual care, with no active screening offered as part of the trial.
OUTCOME ASCERTAINMENT Outcomes are ascertained primarily through linkage to Swedish national health registers (the National Patient Register, the Swedish Prescribed Drug Register, the Cause of Death Register, and quality registers including SWEDEHEART and the Swedish Primary Care Cardiovascular Database) and to regional electronic health records.
SAMPLE SIZE AND ANALYSIS The trial targets identification of 10,000 cardiovascular risk conditions. Analyses follow the intention-to-treat principle.
- Conditions
- Cardiovascular Diseases, Hypertension, Dyslipidemias, Diabetes Mellitus, Atrial Fibrillation, Chronic Kidney Disease
- Being tested
- Home-based multimodal cardiovascular screening
- Keywords
- Population screening, Cardiovascular prevention, Home blood pressure monitoring, Dried blood spot, Digital health, Pragmatic trial, Register-based randomized controlled trial
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Dyslipidemias, Diabetes Mellitus, Atrial Fibrillation, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based multimodal cardiovascular screeningBehavioural
Self-administered home-based screening program: 7-day home BP, DBS biomarker self-sampling, digital questionnaire; structured digital return of results; threshold-based initiation of guideline-recommended pharmacotherapy and referral to clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | Home cardiovascular screening package: 7-day home BP measurement; dried blood spot self-sampling for ApoB, HbA1c and creatinine; digital questionnaire on lifestyle, symptoms, family history, diagnoses, medications. Above-threshold findings trigger initiation of guideline-recommended pharmacotherapy and referral to clinical care. Receives: Behavioral: Home-based multimodal cardiovascular screening |
| Control | No intervention | Usual care. No active screening offered as part of trial. Outcomes via national register and EHR linkage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of total major adverse cardiovascular events over 10 years
Measured: Within 10 years after randomization
Number of initiated guideline-recommended pharmacotherapies for cardiovascular risk factors within 12 months
Measured: Within 12 months after randomization
Secondary outcomes (5)
All-cause mortality
Measured: Within 10 years after randomization.
Rate of cardiovascular deaths
Measured: Within 10 years after randomization.
Rate of total hospitalizations and deaths
Measured: Within 10 years after randomization.
Rate of cardiovascular hospitalizations and deaths from ischaemic heart disease
Measured: Within 10 years after randomization.
Rate of cardiovascular hospitalizations and deaths from cerebrovascular heart disease
Measured: Within 10 years after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Two-arm parallel-group pragmatic randomized controlled trial with 1:1 allocation, stratified by age stratum (50/55/60/65/70/75 years) and sex.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johan Sundström
- Sponsor type
- University, hospital or other
- Collaborators
- Region Uppsala Public Health and Care
- Responsible party
- Sponsor-investigator, Johan Sundström, Uppsala University
- Investigators
- Johan Sundström, MD, PhD, Principal investigator, Uppsala UniversityAnders Wanhainen, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614659
- Sponsor's protocol ID
- U-SCREEN
- Other IDs
- 2024-03135-01
- Acronym
- U-SCREEN
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decisions on sharing of de-identified IPD will follow Swedish and EU data protection legislation and sponsor/Uppsala University policies. Aggregate results will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uppsala Self-Screening of Cardiovascular Health: A Randomized Controlled Trial of Home-Based Multimodal Cardiovascular Screening Versus Usual Care in Middle-Aged and Older Adults
- ClinicalTrials.gov ID
- NCT07614659
- Acronym / sponsor ID
- U-SCREEN / U-SCREEN
- Conditions
- Cardiovascular Diseases, Hypertension, Dyslipidemias, Diabetes Mellitus, Atrial Fibrillation, Chronic Kidney Disease
- Keywords
- Population screening, Cardiovascular prevention, Home blood pressure monitoring, Dried blood spot, Digital health, Pragmatic trial, Register-based randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45,000 participants (estimated)
- Lead sponsor
- Johan SundströmUniversity, hospital or other
- Collaborators
- Region Uppsala Public Health and Care
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 29 May 2026 (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.
U-SCREEN is a randomized controlled trial evaluating whether systematic home-based multimodal screening for cardiovascular risk conditions, offered to residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years of age, can identify clinically actionable cardiovascular risk factors more effectively than usual care. Participants randomized to the screening arm receive a home blood pressure measurement device, a dried blood spot sampling kit (for ApoB, HbA1c and creatinine), and a digital questionnaire. The control arm receives usual care. Recruitment runs 2024-2027 with a target identification of 10,000 cardiovascular risk conditions.
Detailed description
BACKGROUND Cardiovascular disease remains the leading cause of death and disability in Sweden and globally. Hypertension, dyslipidemia, diabetes, atrial fibrillation, and chronic kidney disease are largely asymptomatic but treatable conditions for which effective preventive interventions exist. Despite this, a substantial proportion of affected individuals are undiagnosed or untreated. Population-based screening at clinics is resource-intensive and reaches only a fraction of those at risk. Digital tools and home-based self-sampling now make it feasible to scale cardiovascular screening to whole populations at limited marginal cost.
OBJECTIVES To determine whether a home-based multimodal cardiovascular screening program identifies more cardiovascular risk conditions than usual care in middle-aged and older adults. To evaluate the impact of screening on initiation of evidence-based preventive treatment; on cardiovascular events; on healthcare utilization and costs; and on participant-reported outcomes including health-related quality of life.
DESIGN Pragmatic, register-based, two-arm parallel-group randomized controlled trial. Eligible residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years during the recruitment period are invited and, after digital informed consent, randomized 1:1 to the screening arm or the control arm.
INTERVENTION (SCREENING ARM)
Participants receive a home package containing:
- A validated automated upper-arm blood pressure monitor with instructions for a 7-day home measurement schedule;
- A dried blood spot sampling kit for self-collection and mail-back analysis of ApoB, HbA1c, and creatinine;
- A digital questionnaire on lifestyle, symptoms, family history, and existing diagnoses and medications.
Results are returned to the participant via a digital portal together with structured advice; participants with findings exceeding pre-specified thresholds receive guideline-directed pharmacotherapy and are referred for clinical follow-up in routine care.
COMPARATOR (CONTROL ARM) Usual care, with no active screening offered as part of the trial.
OUTCOME ASCERTAINMENT Outcomes are ascertained primarily through linkage to Swedish national health registers (the National Patient Register, the Swedish Prescribed Drug Register, the Cause of Death Register, and quality registers including SWEDEHEART and the Swedish Primary Care Cardiovascular Database) and to regional electronic health records.
SAMPLE SIZE AND ANALYSIS The trial targets identification of 10,000 cardiovascular risk conditions. Analyses follow the intention-to-treat principle.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel-group pragmatic randomized controlled trial with 1:1 allocation, stratified by age stratum (50/55/60/65/70/75 years) and sex.
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Behavioral: Home-based multimodal cardiovascular screeningHome cardiovascular screening package: 7-day home BP measurement; dried blood spot self-sampling for ApoB, HbA1c and creatinine; digital questionnaire on lifestyle, symptoms, family history, diagnoses, medications. Above-threshold findings trigger initiation of guideline-recommended pharmacotherapy and referral to clinical care. |
| Control | No intervention | –Usual care. No active screening offered as part of trial. Outcomes via national register and EHR linkage. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resident in Region Uppsala, Sweden
- Turning 50, 55, 60, 65, 70 or 75 years during recruitment period
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Protected identity
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 |
|---|---|---|
| Home-based multimodal cardiovascular screeningSelf-administered home-based screening program: 7-day home BP, DBS biomarker self-sampling, digital questionnaire; structured digital return of results; threshold-based initiation of guideline-recommended pharmacotherapy and referral to clinical care. | Behavioural | Screening |
Primary outcome
Rate of total major adverse cardiovascular events over 10 years
Time frame: Within 10 years after randomization
Number of initiated guideline-recommended pharmacotherapies for cardiovascular risk factors within 12 months
Time frame: Within 12 months after randomization
5 secondary outcomes
All-cause mortality
Time frame: Within 10 years after randomization.
Rate of cardiovascular deaths
Time frame: Within 10 years after randomization.
Rate of total hospitalizations and deaths
Time frame: Within 10 years after randomization.
Rate of cardiovascular hospitalizations and deaths from ischaemic heart disease
Time frame: Within 10 years after randomization.
Rate of cardiovascular hospitalizations and deaths from cerebrovascular heart disease
Time frame: Within 10 years after randomization.
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 30 Jun 2026.
- Individual participant dataSharing planned: Undecided. Decisions on sharing of de-identified IPD will follow Swedish and EU data protection legislation and sponsor/Uppsala University policies. Aggregate results will be published in peer-reviewed journals.
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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.
Johan Sundström, MD, PhD principal investigator
Uppsala University
Anders Wanhainen, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based multimodal cardiovascular screening in people with Cardiovascular Diseases and Hypertension, run by Johan Sundström at 1 site in Sweden.
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 3 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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 Sweden. 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?
Contact Johan Sundström, MD, PhD (+46 70 422 52 20, johan.sundstrom@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of total major adverse cardiovascular events over 10 years (time frame: Within 10 years after randomization). 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?
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 30 Jun 2026.