Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

Abstract

IntroductionCardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria.Methods and analysisThe study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia and (4) microalbuminuria (intervention group).Ethics and disseminationThis protocol is approved by the local ethics committee (DK-S-2014007) and The Danish Health and Medicines Authority. Dissemination will occur through presentations at National and International conferences and publications in international peer-reviewed journals.Trial registration numberNCT02246257

Cardiac eccentric remodeling in patients with rheumatoid arthritis

“…This is the case of edema of the ankles that can be confused with swollen joints and/or lung congestion interpreted as pulmonary involvement of RA. For this reason, guidelines for RA state the need to include CUS into to the diagnostic flowchart for CHF, even when is only suspected 25 . So far only CUS markers of diastolic dysfunction 26 – 28 have been associated to RA 29 , 30 , but here we demonstrated that RWT could be added to the list since it is strictly associated to level of inflammation.…”

Development of heart failure in patients with rheumatoid arthritis: A Danish population‐based study

“…40 Further studies are planned to elucidate these issues. 41 4.3 | The modern rheumatoid arthritis therapy did not influence ischaemic heart disease and heart failure incidence…”

“…38 Statins seem to prevent IHD both in low-risk and high-risk patients, which suggest consideration of statin treatment in RA patients. 41 4.3 | The modern rheumatoid arthritis therapy did not influence ischaemic heart disease and heart failure incidence 40 Further studies are planned to elucidate these issues.…”

Effect of high-intensity interval training on muscle remodeling in rheumatoid arthritis compared to prediabetes

“…Despite improvements in rheumatoid arthritis (RA) disease management with biologic therapies, patients with RA remain at greater risk than the general population for cardiovascular disease (CVD) and reduced life expectancy [1–3]. RA-associated CVD, disability, and increased mortality are linked to adverse changes in body composition, including decreased skeletal muscle mass and increased fat mass—referred to as sarcopenic obesity [4, 5].…”