Uppsala Self-Screening of Cardiovascular Health (U-SCREEN)

NCT07614659 | Recruiting DMC

• 2 other identifiers: U-SCREEN2024-03135-01
• Study Type: interventional
• Target: 45,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (2)

• Rate of total major adverse cardiovascular events over 10 years

  Within 10 years after randomization

• Number of initiated guideline-recommended pharmacotherapies for cardiovascular risk factors within 12 months

  Within 12 months after randomization

Secondary Outcomes (5)

• All-cause mortality

  Within 10 years after randomization.

• Rate of cardiovascular deaths

  Within 10 years after randomization.

• Rate of total hospitalizations and deaths

  Within 10 years after randomization.

• Rate of cardiovascular hospitalizations and deaths from ischaemic heart disease

  Within 10 years after randomization.

• Rate of cardiovascular hospitalizations and deaths from cerebrovascular heart disease

  Within 10 years after randomization.

Study Arms (2)

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.

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.

Interventions

Home-based multimodal cardiovascular screening BEHAVIORAL

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.

Screening

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident in Region Uppsala, Sweden
• Turning 50, 55, 60, 65, 70 or 75 years during recruitment period
• Able to provide informed consent

You may not qualify if:

• Inability to provide informed consent
• Protected identity

Sponsors & Collaborators

• Johan Sundström: lead
• Region of Uppsala: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Dyslipidemias; Diabetes Mellitus; Atrial Fibrillation; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Officials

• Johan Sundström, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Anders Wanhainen, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Sundström, MD, PhD

CONTACT

+46 70 422 52 20; johan.sundstrom@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open-label intervention; outcome assessment is performed via blinded extraction from national health registers and electronic health records.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Epidemiology, Consultant in Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 29, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2037
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

SE (1)