Intervention study investigating the effect of a dietary intervention geared towards improved adherence to the Dutch dietary guidelines on the 10-year risk for recurrent vascular events (SMART risk score) in patients with cardiovascular diseases compared with usual care.
- Conditions
- Cardiovascular diseases1008220610003216
- Registration Number
- NL-OMON49536
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
- Be categorised in the highest risk category of the guideline for
cardiovascular risk management 2019 (Tjin-A-Ton, J., & Vrolijk, M., 2019). This
includes patients with:
o Previously diagnosed cardiovascular disease, including acute coronary disease
syndrome, angina, coronary revascularization, TIA or stroke, symptomatic aortic
iliofemoral atherosclerosis, aortic aneurysm, intermittent claudication or
peripheral revascularization.
- Aged 18 year or older.
- Uses medication (e.g. metformine, sulfonylureumderivate, insulin or
DPP4-inhibitors/GLP1-agonists) for treatment of diabetes
- a known hereditary form of cardiovascular diseases (e.g. Familial
hypercholesterolaemia)
- chronic kidney disease in stage 4 or above (meaning an eGFR<30)
o In this case, patients should get dietary advise about their protein intake,
which is not in line with the general advise in our study
- The patient has changes in one or more of the following medication in the
past two weeks: lipid-lowering agents, blood pressure-lowering agents,
glucose-lowering agents and antithrombotics
- The patient participates in another research study of which the outcomes may
interfere with the current trial
- Not able to speak and understand the Dutch language
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The change in Smart Risk Score from baseline until 6 months will be the primary<br /><br>outcome of this study. The SMART Risk Score estimates the 10-year risk for<br /><br>recurrent vascular events in patients with manifest cardiovascular disease<br /><br>based on the following modifiable parameters: systolic blood pressure,<br /><br>creatinine, hsCRP and cholesterol.</p><br>
- Secondary Outcome Measures
Name Time Method