Clinical trial NCT02932644: Vitamin D and Cardiovascular Events in Rheumatoid Arthritis
Official title: Association Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Cardiovascular Disease
Keywords: Rheumatoid Arthritis
Cardiovascular event
Cardiovascular mortality
Vitamin D
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
name: University of Southern Denmark
name: Region of Southern Denmark
name: Pfizer
name: Odense Patient Data Explorative Network
First posted: 2016-10-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hundred-and-sixty early diagnosed and treatment-naive RA patients, recruited from five Danish University Clinics (Trial Centres) from October 1999 to October 2002

Brief summary: The aim of the study is to evaluate cardiovascular events during long-term follow-up in Rheumatoid Arthritis. The primary outcome "any cardiovascular event" will be evaluated using systematic audits of patient records, and will be associated to low levels of vitamin D at baseline, to investigate the hypothesis that low levels of vitamin D can be part of a prediction model for cardiovascular disease in Rheumatoid Arthritis.

Detailed description: Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypo-vitaminosis D is high. Low levels of vitamin D have been associated with elevated cardiovascular risk in healthy subjects. The objective of this study is to evaluate the risk of cardiovascular events in patients having low 25OHD-total levels at baseline compared to patients with sufficient levels, in an aggressively treated closed cohort of early-diagnosed RA patients.

The primary outcome will be the proportion of patients with any cardiovascular event, evaluated using systematic journal audits. Logistic regression models will be applied to test the hypothesis that there are more cardiovascular events in patients enrolled with a low level of vitamin D (\< 50 nmol/l). Secondarily, Cox regression models, based on survival analysis, will be applied, to determine the extent to which independent variables (including different levels of vitamin D at baseline) predict not only whether a cardiovascular event occur, but also when it will occur.

Eligibility criteria: Inclusion Criteria: Fulfilling ACR1987 (American College of Rheumatology 1987 classification criteria for Rheumatoid Arthritis) criteria for RA, disease duration \< 6 months, 2 or more swollen joints and age between 18 and 75 years -

Exclusion Criteria: Glucocorticoid treatment 4 weeks prior to inclusion, previous use of DMARDs, malignancy, diastolic blood pressure \> 90 mm Hg, elevated serum creatinine, infections with parvovirus B19, Hepatitis B, C and HIV, and any condition contraindicating the study medication.

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Primary outcomes:
measure: Cardiovascular event
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
Secondary outcomes:
measure: Acute cardiovascular hospitalisation due to Myocardial Ischamia
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute cardiovascular hospitalisation due to hearth failure
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute cardiovascular hospitalisation due to stroke
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute cardiovascular hospitalisation due to arrhythmias
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute cardiovascular hospitalisation due to Procedure-related cardiovascular event
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute cardiovascular hospitalisation due to other reasons
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute cardiovascular hospitalisation due to supposed cardiovascular reason
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute non-cardiovascular hospitalisation due to cancer
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute non-cardiovascular hospitalisation due to infection
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute non-cardiovascular hospitalisation due to respiratory disease
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute non-cardiovascular hospitalisation due to trauma
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute non-cardiovascular hospitalisation due to suicide
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Acute non-cardiovascular hospitalisation due to other reasons
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective cardiovascular hospitalisation due to myocardial ischemia
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective cardiovascular hospitalisation due to arrhythmia
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective cardiovascular hospitalisation due to heart failure
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective cardiovascular hospitalisation due to other cardiovascular reasons
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective non-cardiovascular hospitalisation due to cancer
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective non-cardiovascular hospitalisation due to infection
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective non-cardiovascular hospitalisation due to respiratory disease
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective non-cardiovascular hospitalisation due to trauma
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Elective non-cardiovascular hospitalisation due to suicide
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Witnessed, sudden cardiovascular death
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Non-witnessed, sudden cardiovascular death
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
measure: Non-sudden cardiovascular death
timeFrame: Observed in the time-period from inclusion to October the 10th 2016
Other outcomes:
Locations:
Study officials:
affiliation: Odense University Hospital
name: Torkell Ellingsen, MD, Phd
role: STUDY_CHAIR
References: