TY - JOUR

T1 - Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis

T2 - protocol for a multicentre randomised controlled trial

AU - Svensson, Annemarie Lyng

AU - Christensen, Robin

AU - Persson, Frederik

AU - Løgstrup, Brian Bridal

AU - Giraldi, Annamaria

AU - Graugaard, Christian

AU - Fredberg, Ulrich

AU - Blegvad, Jesper

AU - Thygesen, Tina

AU - Hansen, Inger Marie Jensen

AU - Colic, Ada

AU - Bagdat, Döne

AU - Ahlquist, Palle

AU - Jensen, Hanne Slott

AU - Hørslev-Petersen, Kim

AU - Sheetal, Ekta

AU - Christensen, Torben Grube

AU - Svendsen, Lone

AU - Emmertsen, Henrik

AU - Ellingsen, Torkell

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/4/20

Y1 - 2016/4/20

N2 - INTRODUCTION: Cardiovascular 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 ANALYSIS: The 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 DISSEMINATION: This 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 NUMBER: NCT02246257.

AB - INTRODUCTION: Cardiovascular 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 ANALYSIS: The 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 DISSEMINATION: This 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 NUMBER: NCT02246257.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Albuminuria

KW - Antirheumatic Agents

KW - Arthritis, Rheumatoid

KW - C-Reactive Protein

KW - Cardiovascular Diseases

KW - Denmark

KW - Female

KW - Hemoglobin A, Glycosylated

KW - Humans

KW - Hyperglycemia

KW - Hyperlipidemias

KW - Hypertension

KW - Hypolipidemic Agents

KW - Lipoproteins, LDL

KW - Male

KW - Middle Aged

KW - Prospective Studies

KW - Research Design

KW - Risk Factors

KW - Severity of Illness Index

KW - Simvastatin

KW - Young Adult

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1136/bmjopen-2015-009134

DO - 10.1136/bmjopen-2015-009134

M3 - Journal article

C2 - 27098820

VL - 6

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 4

M1 - e009134

ER -