Urica Cor Intervention (URICORI) Trial

NCT04459936 | Withdrawn

• 1 other identifier: OL10224607
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout; Cardiovascular Diseases; Dyslipidemias; Hypertension; Diabetes; Behavior, Smoking

Outcome Measures

Primary Outcomes (1)

• Responders (Dichotomised: responder/non-responder)

  Primary end point is a composite endpoint. By inclusion in the URICORI trial 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, range 0-24%). 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.

  1 year from inclusion

Secondary Outcomes (6)

• LDL Cholesterol

  1 year from inclusion

• HbA1c

  1 year from inclusion

• Systolic blood pressure

  1 year from inclusion

• Diastolic blood pressure Change from baseline Diastolic blood pressure (mmHg).

  1 year from inclusion

• Smoking

  1 year from inclusion

Other Outcomes (10)

• LDL cholesterol

  1 and 5 years from inclusion

• HbA1c

  1 and 5 years from inclusion

• Systolic blood pressure

  1 and 5 years from inclusion

Study Arms (2)

Management by Rheumatologist

EXPERIMENTAL

Treatment of modifiable risk factors for cardiovascular disease managed by the Rheumatologist according to national guideline.

Other: URICORI

Management by General Practitioner

ACTIVE COMPARATOR

Treatment of modifiable risk factors for cardiovascular disease managed by the General Practitioner according to national guideline.

Other: CONTROL

Interventions

URICORI OTHER

Treatment for cardiovascular risk factors according to national guideline administered at the department of Rheumatology

Management by Rheumatologist

CONTROL OTHER

Treatment for cardiovascular risk factors according to national guideline administered at the General Practitioner

Management by General Practitioner

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Torkell Ellingsen: lead
• Odense University Hospital: collaborator
• Frederiksberg University Hospital: collaborator
• Oak Foundation: collaborator
• The Danish Rheumatism Association: collaborator
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Gout; Cardiovascular Diseases; Dyslipidemias; Hypertension; Diabetes Mellitus; Smoking

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Vascular Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Behavior

Study Officials

• Melanie Morillon, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The study is a randomised, open label, blinded endpoint trial, with balanced randomisation (1:1)

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: July 7, 2020
• Study Start: November 24, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)