The main objective of this study is to assess the prevalence cardiovascular disease and the prevalence of risk factors for cardiovascular disease in patients with gout, and to quantify the risk for cardiovascular disease in patients with gout. Theā¦
ID
Source
Brief title
Condition
- Joint disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the prevalence of cardiovascular disease
To assess the prevalence of risk factors for cardiovascular disease
To quantify the risk for cardiovascular disease in patients with gout.
Secondary outcome
To investigate the impact of cardiovascular risk management on the risk for
cardiovascular disease in patients with gout in patients who need CV-RM
according to the Dutch guidelines one year after the baseline visit.
To collect more information about the vascular status of patients with
tophaceus gout and contribution of inflammasome activation and oxidative stress
on the atherosclerotic process.
Background summary
Gout is the most prevalent disease within rheumatology. Like other rheumatic
diseases as rheumatoid arthritis and the spondyloarthropathies, there are
indications that the risk for cardiovascular disease is increased in patients
with gout. In daily clinical practice, a strong association between
hyperuricemia, gout and traditional risk factors for cardiovascular disease as
hypertension, dyslipidemia, obesity and diabetes mellitus is observed. The
magnitude of this increased risk and whether this is caused by the increased
prevalence of traditional risk factors alone, or that hyperuricemia and gout
are also independent risk factors for cardiovascular disease, is not yet clear.
Knowledge about the increased risk for cardiovascular disease in patients with
rheumatoid arthritis (RA) and other inflammatory joint diseases has led to the
implementation of cardiovascular risk management in daily clinical practice.
The goal of cardiovascular risk management is to increase the awareness of this
risk and to lower the incidence of cardiovascular morbidity and mortality in
these patients. This can be done by preventive measures regarding lifestyle
factors as stimulating physical exercise and promoting healthy diets, if
necessary in combination with antihypertensive medication or lipid lowering
drugs. Although there is evidence that patients with gout have an increased
risk for cardiovascular disease, in guidelines recommendations with respect to
cardiovascular risk management in patients with gout are lacking. To date, no
studies regarding the effect of cardiovascular risk management in gout patients
have been conducted, but is likely that in this patient population
cardiovascular risk management will lead to a reduction of cardiovascular
morbidity and mortality. In summary, there are indications that the risk for
cardiovascular disease is increased in patients with gout. However, data about
the contribution of individual risk factors is lacking. Available data with
respect to the effect of gout treatment on cardiovascular disease are
inconclusive. To gain insight in these risk factors, the magnitude of the
increased cardiovascular risk and to improve management of cardiovascular risk
in patients with gout, data of a larger group of patients should be
systematically recorded and evaluated.
Study objective
The main objective of this study is to assess the prevalence cardiovascular
disease and the prevalence of risk factors for cardiovascular disease in
patients with gout, and to quantify the risk for cardiovascular disease in
patients with gout. The secondary objective is to investigate the impact of
cardiovascular risk management on the risk for cardiovascular disease in
patients with gout in patients who need CV-RM according to the Dutch
guidelines. The third objective is to get a closer view on the immune system
activation (in particular inflammasome) in gout and the possible relationship
with the atherosclerotic process.The data that will be collected in this study
will serve as the base for a registry of the patients of Reade diagnosed with
gout.
Study design
To be able to address the main objective of this study, a cross sectional study
is designed. At this single (baseline) visit demographic, disease specific,
cardiovascular and laboratory data will be collected. To evaluate efficacy of
cardiovascular risk management, one year later, data with respect to the
cardiovascular morbidity and mortality and cardiovascular risk actors will be
collected.
From all patients, 20 patients with tophaceous gout will be asked to
participate in a subgroup analysis and will go through an extra set of
additional examination consisting of ultrasonography, pulse wave velocity
measurement and DECT-scan.
Study burden and risks
The results of this study will contribute to the knowledge about the increased
risk of cardiovascular disease in gout patients and the influence of
cardiovascular risk management in this group of patients. Individual subjects
will gain no direct benefit from this study. The risk of participating in this
study is estimated to be low. The patients will visit our outpatient clinic on
2 occasions for medical history, cardiovascular risk assessment and blood
withdrawal.
The extra blood that will be collected for this study will be collected during
regular blood sampling. This includes 12.5 ml that will be stored at Reade for
the purpose to answer future research questions about cardiovascular disease in
gout patients. In addition, during the first visit 22 ml of additional blood
will be taken for the purpose of future research into genetic factors that may
play a role in gout and cardiovascular disorders.
Furthermore, urine is stored with the aim to carry out further urine testing
when necessary for future research questions.
Patients in the subgroup analysis are exposed to radiation once, while
undergoing the DECT-scan.
dr Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
dr Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
Patients:
- Aged 18 years or older
- Diagnosis of gout (first or recurrent episode) confirmed by a rheumatologist
Exclusion criteria
No informed consent
Insufficient language proficiency
Design
Recruitment
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 |
---|---|
CCMO | NL46304.048.14 |