Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932644
• Other study ID #: 3-3013-930/1/
• Status: Completed
• Phase: N/A
• First received: October 12, 2016
• Last updated: October 12, 2016
• Start date: October 1999
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Cardiovascular Disease
• Cardiovascular Diseases
• Rheumatoid Arthritis

Intervention

Other:
• Baseline serum vitamin D level below 50 nmol/l
There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis
• Baseline serum vitamin D level at or above 50 nmol/l
There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Odense University Hospital	Odense Patient Explorative data Network (OPEN), Pfizer, Region of Southern Denmark, The Danish Rheumatism Association, University of Southern Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular event	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"	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute cardiovascular hospitalisation due to Myocardial Ischamia	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).	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute cardiovascular hospitalisation due to hearth failure	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.	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute cardiovascular hospitalisation due to stroke	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	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute cardiovascular hospitalisation due to arrhythmias	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	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute cardiovascular hospitalisation due to Procedure-related cardiovascular event	Any cardiovascular event within 24 hours after cardiovascular medical examination/procedure/surgery.	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute cardiovascular hospitalisation due to other reasons	Hospitalisation caused by other cardiovascular events, e.g. pulmonary embolism, rupture of aortic aneurism etc.	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute cardiovascular hospitalisation due to supposed cardiovascular reason	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	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute non-cardiovascular hospitalisation due to cancer	Acute hospitalisation due to cancer	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute non-cardiovascular hospitalisation due to infection	Acute hospitalisation due to infection	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute non-cardiovascular hospitalisation due to respiratory disease	Acute hospitalisation due to respiratory disease	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute non-cardiovascular hospitalisation due to trauma	Acute hospitalisation due to trauma	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute non-cardiovascular hospitalisation due to suicide	Acute - hospitalisation due to suicide	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Acute non-cardiovascular hospitalisation due to other reasons	Acute hospitalisation du to other non-cardiovascular reasons, than those previous mentioned	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective cardiovascular hospitalisation due to myocardial ischemia		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective cardiovascular hospitalisation due to arrhythmia		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective cardiovascular hospitalisation due to heart failure		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective cardiovascular hospitalisation due to other cardiovascular reasons		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective non-cardiovascular hospitalisation due to cancer		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective non-cardiovascular hospitalisation due to infection		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective non-cardiovascular hospitalisation due to respiratory disease		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective non-cardiovascular hospitalisation due to trauma		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Elective non-cardiovascular hospitalisation due to suicide		Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Witnessed, sudden cardiovascular death	Death is witnessed and abrupt within one hour after symptom-onset	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Non-witnessed, sudden cardiovascular death	Non-witnessed death with no obvious non-cardiovascular reasons (found death)	Observed in the time-period from inclusion to October the 10th 2016	No
Secondary	Non-sudden cardiovascular death	Death due to any of the cardiovascular caused previously mentioned, more than one hour after symptom-onset	Observed in the time-period from inclusion to October the 10th 2016	No