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Completed

NCT Number: NCT02932644

Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiovascular Disease Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Baseline serum vitamin D level below 50 nmol/l

Other

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

Other

There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis

Primary outcomes

  1. Cardiovascular event

    Time frame: 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 outcomes

  1. Acute cardiovascular hospitalisation due to Myocardial Ischamia

    Time frame: 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).

  2. Acute cardiovascular hospitalisation due to hearth failure

    Time frame: 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.

  3. Acute cardiovascular hospitalisation due to stroke

    Time frame: 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

  4. Acute cardiovascular hospitalisation due to arrhythmias

    Time frame: 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

  5. Acute cardiovascular hospitalisation due to Procedure-related cardiovascular event

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Any cardiovascular event within 24 hours after cardiovascular medical examination/procedure/surgery.

  6. Acute cardiovascular hospitalisation due to other reasons

    Time frame: 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.

  7. Acute cardiovascular hospitalisation due to supposed cardiovascular reason

    Time frame: 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

  8. Acute non-cardiovascular hospitalisation due to cancer

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Acute hospitalisation due to cancer

  9. Acute non-cardiovascular hospitalisation due to infection

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Acute hospitalisation due to infection

  10. Acute non-cardiovascular hospitalisation due to respiratory disease

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Acute hospitalisation due to respiratory disease

  11. Acute non-cardiovascular hospitalisation due to trauma

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Acute hospitalisation due to trauma

  12. Acute non-cardiovascular hospitalisation due to suicide

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Acute - hospitalisation due to suicide

  13. Acute non-cardiovascular hospitalisation due to other reasons

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Acute hospitalisation du to other non-cardiovascular reasons, than those previous mentioned

  14. Elective cardiovascular hospitalisation due to myocardial ischemia

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  15. Elective cardiovascular hospitalisation due to arrhythmia

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  16. Elective cardiovascular hospitalisation due to heart failure

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  17. Elective cardiovascular hospitalisation due to other cardiovascular reasons

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  18. Elective non-cardiovascular hospitalisation due to cancer

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  19. Elective non-cardiovascular hospitalisation due to infection

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  20. Elective non-cardiovascular hospitalisation due to respiratory disease

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  21. Elective non-cardiovascular hospitalisation due to trauma

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  22. Elective non-cardiovascular hospitalisation due to suicide

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

  23. Witnessed, sudden cardiovascular death

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Death is witnessed and abrupt within one hour after symptom-onset

  24. Non-witnessed, sudden cardiovascular death

    Time frame: Observed in the time-period from inclusion to October the 10th 2016

    Non-witnessed death with no obvious non-cardiovascular reasons (found death)

  25. Non-sudden cardiovascular death

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Odense Patient Data Explorative Network
  • Pfizer
  • Region of Southern Denmark
  • The Danish Rheumatism Association
  • University of Southern Denmark

Registry information

Official study 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.

Important dates

Study start
1999
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2016
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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