RED-LRGP: To investigate the yield of a screen-like early diagnosis strategy as compared to usual primary care in terms of the number of newly diagnosed coronary artery disease, atrial fibrillation, and heart failure in community people aged 50-80…
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
hartaandoeningen: kransslagaderaandoeningen, falen van de hartfunctie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
RED-LRGP:
The primary outcomes are newly detected CAD, AF and HF after one year
follow-up.
Secondary outcome
RED-LRGP:
- Health-related quality of life
- Cost-effectivity
Night-LRGP:
The primary outcome is the user-friendliness and usability of the Omron
NightView as compared to the ABPM notably for measurements at night.
Background summary
There is a need for a proactive strategy for early detection of chronic
progressive cardiovascular diseases, notably those in the cardiac *continuum*
namely coronary artery disease (CAD), atrial fibrillation (AF), and heart
failure (HF). By early detection and management of CAD, AF and HF, acute
events, e.g. acute myocardial infarction, stroke, or acute heart failure, may
be prevented and further deterioration of disease prevented or postponed. So
far, such an early detection strategy in the open adult population is lacking.
Study objective
RED-LRGP:
To investigate the yield of a screen-like early diagnosis strategy as compared
to usual primary care in terms of the number of newly diagnosed coronary artery
disease, atrial fibrillation, and heart failure in community people aged 50-80
years.
Night-LRGP:
To investigate the user-friendliness and usability of the Omron NightView
device as compared to a conventional ABPM device for blood pressure
measurements notably at night.
Study design
RED-LRGP:
A diagnostic randomized trial comparing the full, screen-like early diagnosis
strategy to usual care.
Night-LRGP:
A cross-over trial on the user-friendliness and usability of the Omron
NightView vs. conventional 24 hours ABPM.
Intervention
RED-LRGP:
Participants will be randomized to 1) the intervention group (early diagnosis
strategy), or 2) control group (usual primary care)
1) Participants in the intervention group will fill out the 'early diagnosis
questionnaire' and additional questionnaires. In addition, they will undergo a
physical examination, electrocardiography, and echocardiography. Blood samples
will also be drawn and a spot urine sample will be collected.
2) Participants in the control group will receive usual primary care. No
measurements will be performed.
Night-LRGP:
Participants undergo blood pressure measurements at home with the NightView
device and a regular ABPM.
Study burden and risks
The burden associated with participation in the RED-LRGP study will be
relatively low as only two extra visits will be required. Participants will be
asked to fill out questionnaires and those randomized to the intervention arm
will also undergo a physical examination, electrocardiography,
echocardiography, and laboratory testing. The RED-LRGP study is a low-risk
study, as all are established non-invasive and minimally invasive (blood
taking) diagnostic tests. The results of the investigations in the study will
be shared with the treating general practitioner to help him/her make
management choices. There is a potential benefit associated with participation,
since we aim to uncover early stages of CVD that might have not been detected
otherwise, and for which early treatment options are available.
The burden associated with participation in the Night-LRGP study will also be
relatively low, as only two extra visits are required. Participants will be
asked to fill out questionnaires and blood pressure will be measured at home
over several days and nights. This can potentially lead to a reduction in sleep
quality. There is a potential benefit associated with participation, as high
blood pressure can be detected and treated early, or treatment for high blood
pressure can be adjusted.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05775354 |
| CCMO | NL82944.041.23 |