Related Experiment Video
Updated: Mar 22, 2026
Preliminary Study on Acupuncture Combined with Grain-sized Moxibustion for Treating Rheumatoid Arthritis with Finger Joint Pain
Published on: May 16, 2025
Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol
Annemarie Lyng Svensson1, Robin Christensen2, Frederik Persson3
1Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.
Insights
This study investigates an intensified intervention for cardiovascular risk factors in early rheumatoid arthritis (RA) patients. The goal is to reduce cardiovascular disease (CVD) burden compared to conventional care.
Area of Science:
- Rheumatology
- Cardiology
- Public Health
Background:
- Cardiovascular morbidity is a significant concern for patients with rheumatoid arthritis (RA).
- Early RA patients meeting 2010 ACR/EULAR criteria are at increased risk for cardiovascular disease (CVD).
- This study compares a novel multifactorial intervention against standard care for managing modifiable CVD risk factors in early RA.
Purpose of the Study:
- To evaluate the efficacy of a targeted, intensified, multifactorial intervention in reducing cardiovascular events in early RA patients.
- To compare the intervention's impact on risk factors (cholesterol, HbA1c, blood pressure, albuminuria) versus conventional treatment.
- To assess the intervention's effect on rheumatoid arthritis disease activity.
Main Methods:
- A prospective, randomized, open-label trial with blinded endpoint assessment (1:1 randomization).
- 10 outpatient clinics in Denmark are involved, enrolling 300 treatment-naive early RA patients.
- The intervention group receives nurse-administered behavior modification and pharmacotherapy targeting hyperlipidemia, hypertension, hyperglycemia, and microalbuminuria; the control group receives conventional GP-managed care.
Main Results:
- The primary endpoint is a composite of cardiovascular death, myocardial infarction, stroke, and revascularization after 5 years.
- Secondary outcomes include achieving specific targets for LDL cholesterol, HbA1c, blood pressure, and normoalbuminuria after 1 year.
- RA disease activity (DAS28-CRP) and hospitalization rates will also be assessed over 5 years.
Conclusions:
- The study aims to determine if an intensified, multifactorial intervention can significantly decrease cardiovascular morbidity in early RA patients.
- Findings will inform clinical practice regarding proactive CVD risk management in this population.
- The trial will provide valuable data on the comprehensive management of RA and its associated cardiovascular complications.
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.
Related Concept Videos
01:21Rheumatic Heart Disease III: Medical Management
01:23Rheumatic Heart Disease I: Introduction
01:20Rheumatic Heart Disease IV: Nursing Management
01:26Atherosclerosis III: Management
01:22Rheumatic Heart Disease II: Clinical Manifestations and Diagnostic Studies
01:26Coronary Artery Disease IV: Preventive Measures