Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis; Cardiovascular Disease
• Interventions: Other: Baseline serum vitamin D level below 50 nmol/l; Other: Baseline serum vitamin D level at or above 50 nmol/l

• Registration Number: NCT02932644
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 1999-10
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Last Update Submitted: 2016-10-12
• Study First Posted: 2016-10-13
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 -

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis patients	Baseline serum vitamin D level below 50 nmol/l	Participants in the original, parental trial
Rheumatoid arthritis patients	Baseline serum vitamin D level at or above 50 nmol/l	Participants in the original, parental trial

Primary Outcome Measures

Name	Time	Method
Cardiovascular event	Observed in the time-period from inclusion to October the 10th 2016	Events will be recorded using systematic journal audits. A cardiovascular event will be further subclassified as shown in the secondary outcome measures, but for primary outcome measures; any cardiovascular event, including death, will serve as "an event"

Secondary Outcome Measures

Name	Time	Method
Acute non-cardiovascular hospitalisation due to infection	Observed in the time-period from inclusion to October the 10th 2016	Acute hospitalisation due to infection
Acute non-cardiovascular hospitalisation due to respiratory disease	Observed in the time-period from inclusion to October the 10th 2016	Acute hospitalisation due to respiratory disease
Acute non-cardiovascular hospitalisation due to trauma	Observed in the time-period from inclusion to October the 10th 2016	Acute hospitalisation due to trauma
Acute cardiovascular hospitalisation due to Myocardial Ischamia	Observed in the time-period from inclusion to October the 10th 2016	Non-fatal or fatal myocardial infarction, defined by National and International Guidelines (Thygesen et al. 1581-98).; Fatal myocardial infarction is defined as primary fatal event within 7 days, documented post mortem by autopsy, or by the definition of myocardial infarction according to European Guidelines (Thygesen et al. 1581-98) Death of myocardial infarction as a consequence of medical examination/procedure/surgery will be classified as procedure related death.; Acute Coronary Syndrome (ACS) includes acute ischaemic symptoms with eventual elevation in biomarkers or electrocardiographic changes which does not fulfil the criteria of acute myocardial infarction.; Angina Pectoris. Revascularisation procedures (Percutaneous Coronary Intervention (PCI) or Coronary bypass Graft (CABG).
Acute cardiovascular hospitalisation due to hearth failure	Observed in the time-period from inclusion to October the 10th 2016	Patients with non-elective hospitalisation or death, minimum one overnight stay, with symptoms or findings of heart failure.; Death due to heart failure is defined as escalating heart failure symptoms prior to death.
Acute cardiovascular hospitalisation due to stroke	Observed in the time-period from inclusion to October the 10th 2016	Cerebral haemorrhage, cerebral thromboembolism, Transitory Cerebral Ischemia (TCI) and others Stroke is defined as abrupt severe neurologic deficits, eventually with computer tomographic (CT) documentation. Death within 14 days after symptom-onset of stroke, and without other obviously reasons, is classified as caused by stroke
Acute cardiovascular hospitalisation due to arrhythmias	Observed in the time-period from inclusion to October the 10th 2016	Atrial fibrillation or flutter, supraventricular tachycardia and others. Ventricular tachycardia, ventricular fibrillation and others. Death due to arrhythmia requires documentation, e.g. telemetric transcript, pacemaker or electrocardiogram
Acute cardiovascular hospitalisation due to Procedure-related cardiovascular event	Observed in the time-period from inclusion to October the 10th 2016	Any cardiovascular event within 24 hours after cardiovascular medical examination/procedure/surgery.
Acute cardiovascular hospitalisation due to other reasons	Observed in the time-period from inclusion to October the 10th 2016	Hospitalisation caused by other cardiovascular events, e.g. pulmonary embolism, rupture of aortic aneurism etc.
Acute cardiovascular hospitalisation due to supposed cardiovascular reason	Observed in the time-period from inclusion to October the 10th 2016	Hospitalisation without any documented non-cardiovascular cause. All deaths which are not defined by the cardiovascular reasons mentioned above, and who are not caused by well-documented non-cardiovascular death.; All deaths without known reason
Acute non-cardiovascular hospitalisation due to cancer	Observed in the time-period from inclusion to October the 10th 2016	Acute hospitalisation due to cancer
Elective cardiovascular hospitalisation due to arrhythmia	Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to respiratory disease	Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to trauma	Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to suicide	Observed in the time-period from inclusion to October the 10th 2016
Witnessed, sudden cardiovascular death	Observed in the time-period from inclusion to October the 10th 2016	Death is witnessed and abrupt within one hour after symptom-onset
Non-witnessed, sudden cardiovascular death	Observed in the time-period from inclusion to October the 10th 2016	Non-witnessed death with no obvious non-cardiovascular reasons (found death)
Non-sudden cardiovascular death	Observed in the time-period from inclusion to October the 10th 2016	Death due to any of the cardiovascular caused previously mentioned, more than one hour after symptom-onset
Acute non-cardiovascular hospitalisation due to suicide	Observed in the time-period from inclusion to October the 10th 2016	Acute - hospitalisation due to suicide
Acute non-cardiovascular hospitalisation due to other reasons	Observed in the time-period from inclusion to October the 10th 2016	Acute hospitalisation du to other non-cardiovascular reasons, than those previous mentioned
Elective cardiovascular hospitalisation due to myocardial ischemia	Observed in the time-period from inclusion to October the 10th 2016
Elective cardiovascular hospitalisation due to heart failure	Observed in the time-period from inclusion to October the 10th 2016
Elective cardiovascular hospitalisation due to other cardiovascular reasons	Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to cancer	Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to infection	Observed in the time-period from inclusion to October the 10th 2016