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

protocol for a multicentre randomised controlled trial

Annemarie Lyng Svensson, Robin Christensen, Frederik Persson, Brian Bridal Løgstrup, Annamaria Giraldi, Christian Graugaard, Ulrich Fredberg, Jesper Blegvad, Tina Thygesen, Inger Marie Jensen Hansen, Ada Colic, Döne Bagdat, Palle Ahlquist, Hanne Slott Jensen, Kim Hørslev-Petersen, Ekta Sheetal, Torben Grube Christensen, Lone Svendsen, Henrik Emmertsen, Torkell Ellingsen

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Abstract

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.

Original languageEnglish
JournalB M J Open
Volume6
Issue number4
Pages (from-to)e009134
ISSN2044-6055
DOIs
Publication statusPublished - 2016

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Randomized Controlled Trials
Ethics Committees
Glycosylated Hemoglobin A
Denmark
Random Allocation
Ambulatory Care Facilities
Hyperlipidemias
Hyperglycemia
LDL Cholesterol
General Practitioners
Publications
Cause of Death
Albumins
Creatinine
Nurses
Guidelines
Control Groups
Health

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Svensson, Annemarie Lyng ; Christensen, Robin ; Persson, Frederik ; Løgstrup, Brian Bridal ; Giraldi, Annamaria ; Graugaard, Christian ; Fredberg, Ulrich ; Blegvad, Jesper ; Thygesen, Tina ; Hansen, Inger Marie Jensen ; Colic, Ada ; Bagdat, Döne ; Ahlquist, Palle ; Jensen, Hanne Slott ; Hørslev-Petersen, Kim ; Sheetal, Ekta ; Christensen, Torben Grube ; Svendsen, Lone ; Emmertsen, Henrik ; Ellingsen, Torkell. / Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis : protocol for a multicentre randomised controlled trial. In: B M J Open. 2016 ; Vol. 6, No. 4. pp. e009134.
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Svensson, AL, Christensen, R, Persson, F, Løgstrup, BB, Giraldi, A, Graugaard, C, Fredberg, U, Blegvad, J, Thygesen, T, Hansen, IMJ, Colic, A, Bagdat, D, Ahlquist, P, Jensen, HS, Hørslev-Petersen, K, Sheetal, E, Christensen, TG, Svendsen, L, Emmertsen, H & Ellingsen, T 2016, 'Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial', B M J Open, vol. 6, no. 4, pp. e009134. https://doi.org/10.1136/bmjopen-2015-009134

Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis : protocol for a multicentre randomised controlled trial. / Svensson, Annemarie Lyng; Christensen, Robin; Persson, Frederik; Løgstrup, Brian Bridal; Giraldi, Annamaria; Graugaard, Christian; Fredberg, Ulrich; Blegvad, Jesper; Thygesen, Tina; Hansen, Inger Marie Jensen; Colic, Ada; Bagdat, Döne; Ahlquist, Palle; Jensen, Hanne Slott; Hørslev-Petersen, Kim; Sheetal, Ekta; Christensen, Torben Grube; Svendsen, Lone; Emmertsen, Henrik; Ellingsen, Torkell.

In: B M J Open, Vol. 6, No. 4, 2016, p. e009134.

Research output: Contribution to journalJournal articleResearchpeer-review

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

Y1 - 2016

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.

U2 - 10.1136/bmjopen-2015-009134

DO - 10.1136/bmjopen-2015-009134

M3 - Journal article

VL - 6

SP - e009134

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 4

ER -