Treating the compromised hearts of patients with Rheumatoid Arthritis ¨C Can we repair the damage?

Rationale: RA patients have an increased risk for developing heart failure with preserved ejection fraction (HFpEF) compared to the normal population. Accumulating evidence shows that systemic inflammatory disease activity in general plays a pivotal role in development of cardiac dysfunction. We therefore expect the diastolic function to improve in RA patients after aggressive anti-inflammatory treatment with anti-TNF.
Objective: Primary Objective: To investigate diastolic LV dysfunction before and after 6 months anti-inflammatory treatment with TNF blockers in patients with RA, assessed by exercise-stress echocardiography. Secondary objectives: To investigate whether systolic LV function improves in patients with RA during treatment with anti-inflammatory therapy with TNF blockers resulting in lower disease activity.
Study design: A prospective cohort study in RA patients indicated for anti-TNF therapy who undergo exercise-stress echocardiography before start of therapy. Patients with diastolic dysfunction at baseline will undergo a second exercise-stress echocardiography after 6 months anti-TNF treatment.
Study population: Fifty RA patients between 40-70 years with active disease characterized as DAS28≥3.2 AND C-reactive protein >10 mg/l OR erythrocyte sedimentation rate (ESR) >15mm/h).
Intervention (if applicable): N/A
Main study parameters/endpoints: The main study parameter is change in echocardiographic parameters before and after 6 months anti-inflammatory treatment with anti-TNF.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are some aspects to this protocol that may cause (some) a limited discomfort, however, we do not expect any severe risks as consequence of the study procedure. This study may improve our understanding of the role of inflammation on cardiac dysfunction and the possible reversibility of cardiac dysfunction. Therefore this is has potential to decrease the risk of development of heart failure with preserved ejection fraction in RA patients.

We hypothesize that diastolic LV function improves in RA patients responding to anti-inflammatory treatment. Adequate and effective anti-inflammatory treatment can reduce the risk of HFpEF, especially in patients with a high cardiovascular risk profile.

baseline and (if applicable) 6 months follow up