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 cardiovasculardisease (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 pointassessment 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, nonfatal 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 aquarterly 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.
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 cardiovasculardisease (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 pointassessment 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, nonfatal 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 aquarterly 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.
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
SN - 2044-6055
VL - 6
JO - B M J Open
JF - B M J Open
IS - 4
M1 - e009134
ER -
