Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

Recruiting

Conditions: hartaandoeningen: kransslagaderaandoeningen, falen van de hartfunctie
1) atrial fibrillation
2) coronary artery disease
3) heart failure
10007521

Registration Number: NL-OMON56354

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1464

Inclusion Criteria

RED-LRGP:
- Being a participant of Utrecht Health Project (UHP; in Dutch: Leidsche Rijn
Gezondheidsproject (LRGP)) and registered with a general practitioner at the
Leidsche Rijn Julius Health Care foundation (in Dutch: Leidsche Rijn Julius
Gezondheidcentra).
- Having indicated in the LRGP informed consent to be interested in
participating in further research.
- Aged 50-80 years.

Night-LRGP:
- Being a participant of the RED-LRGP study and enrolled in the intervention
arm.
- Willing to undergo multiple ambulatory day and multiple night BP measurements
with the Omron NightView and a conventional BP measurement device and to fill
out questionnaires on user-friendliness and quality of sleep.

Exclusion Criteria

RED-LRGP:
- Diagnosed with coronary artery disease and heart failure and atrial
fibrillation.
- 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
general practitioner.

Night-LRGP:
- Known with permanent atrial fibrillation; this hampers automatic blood
pressure measurements.
- Not willing or able to give informed consent for Night-LRGP.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>RED-LRGP:<br /><br>The primary outcomes are newly detected CAD, AF and HF after one year<br /><br>follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>RED-LRGP:<br /><br>- Health-related quality of life<br /><br>- Cost-effectivity<br /><br><br /><br>Night-LRGP:<br /><br>The primary outcome is the user-friendliness and usability of the Omron<br /><br>NightView as compared to the ABPM notably for measurements at night. </p><br>