Clinical trial NCT04459936: Urica Cor Intervention (URICORI) Trial
Official title: A Multifactorial 'Urica Cor Intervention' to Prevent Cardiovascular Disease in People With Gout: Protocol for the Multicentre, Randomised Controlled, Blinded Endpoint URICORI Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gout
Cardiovascular Diseases
Dyslipidemias
Hypertension
Diabetes
Behavior, Smoking
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Frederiksberg University Hospital
name: Oak Foundation
name: The Danish Rheumatism Association
name: Region of Southern Denmark
name: University of Southern Denmark
First posted: 2020-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomised, open label, blinded endpoint trial, with balanced randomisation (1:1)
Primary purpose: TREATMENT

Brief summary: The objective of the Urica Cor Intervention (URICORI) trial is to evaluate the effectiveness of a one-year, intervention of modifiable risk factors for CVD administered in a rheumatology outpatient clinical setting, compared with conventional treatment for modifiable risk factors for CVD in people with gout.

Detailed description: Introduction: Gout has been associated with a number of comorbidities including cardiovascular disease (CVD). Mounting evidence suggests that hyperuricaemia and gout are associated with a high risk for CVD. Gout is closely related to hypertension, dyslipidaemia, obesity and metabolic syndrome, all well-known factors contributing to the development of CVD. Gout management guidelines all agree that comorbidity screening is relevant and thus should be implemented in contemporary gout management. However, no specific strategy for management of CVD risk factors, in a gout population, exists.

Objective: The objective of the Urica Cor Intervention (URICORI) trial is to evaluate the effectiveness of a one-year, intervention of modifiable risk factors for CVD administered in a rheumatology outpatient clinical setting, compared with conventional treatment for modifiable risk factors for CVD in people with gout.

Design: The study is a randomised, open label, blinded endpoint trial, with balanced randomisation (1:1) conducted in four rheumatology outpatient clinics in Denmark. The investigators aim to recruit 266 people with gout, fulfilling the current EULAR ( European League against Rheumatism)/ ACR (American College of Rheumatology) gout classification criteria. Eligible patients will be randomised to receive either conventional (control group) treatment for CVD risk factors administered by their general practitioner according to national guidelines (NG) versus the URICORI programme, administered at the rheumatology department, targeting the same CVD risk factors according to NG. Both groups will be treated for gout at their local department of rheumatology.

End Points: primary end point is a composite endpoint. By inclusion in the URICORI programme all participants will be considered a member of one of four categories derived from the Systematic Coronary Risk Estimation (SCORE) screening programme designed to assess the 10 year risk of fatal cardiovascular disease in European low risk population. As a consequence, participants will be classified as responder after 12 months if all national treatment targets for LDL cholesterol, HbA1c, Blood pressure (systolic and diastolic), according to their SCORE risk profile, is met and no commencement of smoking. If not, participants will be classified as non-responders.

Key secondary end points: Change from baseline of LDL cholesterol, HbA1c, systolic blood pressure, diastolic blood pressure, smoking status and change from baseline in serum urate. Exploratory end points: Proportion of participants achieving treatment target for LDL cholesterol, HbA1c, systolic blood pressure, diastolic blood pressure, change in smoking status (commencement and cessation) and proportion of participants achieving serum urate \< 36.0 mmol/l or serum urate \< 0.30 mmol/l for tophaceous disease.

After year 1 and year 5, the first occurrence of any serious cardiovascular event (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or urgent revascularization due to unstable angina) during the URICORI trial will be registered. Death and hospitalisation during the URICORI trial will also be evaluated after year 5. Events will be determined by medical record review and evaluated by the endpoint adjudication committee. The Outcome Measures in Rheumatology (OMERACT) endorsed Core Domain Set for us in trials in gout will measured during and after the one-year URICORI intervention trial.

Ethics and dissemination: The local ethics committee in the region of southern Denmark and the Danish data agency in the region of southern Denmark will approve this protocol prior to commencement.

Eligibility criteria: Inclusion Criteria:

* Gout according to current EULAR/ACR (American College of Rheumatology) gout classification criteria
* Age \>18 years
* Plasma LDL \>3.0 mmol/L
* Agreeable to start treatment for CVD risk factors if indicated
* Ability to give informed consent
* Ability to communicate via telephone

Exclusion Criteria:

* Other inflammatory diseases requiring immunosuppressant therapy.
* Age \>70 years.
* Active cancer (in active treatment).
* Chronic kidney disease (eGFR \<30 ml/min/1.73m2).
* People whose behaviour or lifestyle would render them less likely to comply with the study protocol (i.e., abuse of alcohol, substance misuse or debilitating psychiatric conditions).
* Familial hypercholesterolemia.

Primary outcomes:
measure: Responders (Dichotomised: responder/non-responder)
timeFrame: 1 year from inclusion
Secondary outcomes:
measure: LDL Cholesterol
timeFrame: 1 year from inclusion
measure: HbA1c
timeFrame: 1 year from inclusion
measure: Systolic blood pressure
timeFrame: 1 year from inclusion
measure: Diastolic blood pressure Change from baseline Diastolic blood pressure (mmHg).
timeFrame: 1 year from inclusion
measure: Smoking
timeFrame: 1 year from inclusion
measure: Serum Urate
timeFrame: 1 year from inclusion
Other outcomes:
measure: LDL cholesterol
timeFrame: 1 and 5 years from inclusion
measure: HbA1c
timeFrame: 1 and 5 years from inclusion
measure: Systolic blood pressure
timeFrame: 1 and 5 years from inclusion
measure: Diastolic blood pressure
timeFrame: 1 and 5 years from inclusion
measure: Smoking
timeFrame: 1 and 5 years from inclusion
measure: Serum urate
timeFrame: 1 and 5 years from inclusion
measure: Cardiovascular event
timeFrame: 1 year form inclusion
measure: Serious cardiovascular event
timeFrame: 5 years from inclusion
measure: Death
timeFrame: 5 years from inclusion
measure: Hospitalisation
timeFrame: 5 years from inclusion
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Melanie Morillon, MD
role: PRINCIPAL_INVESTIGATOR
References: