Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

Not Applicable

• Conditions: Heart Failure; Atrial Fibrillation; Valvular Heart Disease; Coronary Artery Disease
• Interventions: Diagnostic Test: Early diagnosis strategy

• Registration Number: NCT05775354
• Lead Sponsor: UMC Utrecht

Brief Summary

The goal of this randomized trial is to compare the diagnostic yield of a screen-like early diagnosis strategy to usual primary care to detect coronary artery disease (CAD), atrial fibrillation (AF), heart failure (HF), and/or valvular heart disease (VHD) in community people aged 50-80 years who participate in the Utrecht Health Project.

The diagnosis strategy consists of a questionnaire with questions related to symptoms suggestive of CAD, AF or HF, a focused physical examination, laboratory testing, electrocardiography, and echocardiography.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Study Start: 2023-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Primary Completion: 2026-05
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1476

Inclusion Criteria

• Aged 50-80 years
• Being a participant of LRGP
• Having indicated in the LRGP informed consent to be interested in participating in further research.

Exclusion Criteria

• Diagnosed with coronary artery disease and atrial fibrillation and heart failure.
• Undergoing major (cardiovascular) surgery, and/or revascularisation therapy and/or transplantation treatment within 3 months after enrolment.
• Not willing to give written informed consent for RED-LRGP.
• Not allowing incidental findings to be reported to him/herself or their own GP.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early diagnosis strategy	Early diagnosis strategy	RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	1 year
Coronary artery disease	1 year
Heart failure	1 year
Valvular heart disease	1 year

Secondary Outcome Measures

Name	Time	Method
Echocardiographic abnormalities	1 year
Health-related quality of life	1 year
CVD family history and women's reproductive history	1 year
Cardiovascular risk profile	1 year
Costs	1 year

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands