This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor Vanderbilt University
Collaborator Arthritis Foundation
Start date August 2012
End date December 2017
Trial size 345 participants
Trial identifier NCT01589770, 120314


Studies have shown that people with rheumatoid arthritis (RA) have a higher rate of heart disease than people that do not have RA. we believe this is caused by the inflammation produced by RA.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
People who have rheumatoid arthritis
people who do not have RA or other inflammatory disease

Primary Outcomes

change in myocardial size and contractility measured by MRI
time frame: before, and 6 months (24 weeks) after, starting disease modifying therapy

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Written informed consent - Age >= 18 - RA only: meet American College of Rheumatology(ACR)criteria for Diagnosis of RA - Controls only: no evidence of RA or other inflammatory disease Exclusion Criteria: - Previous or current heart failure or ischemic cardiovascular disease (eg stroke, myocardial infarction, angina, CABG, stent). - Atrial fibrillation. - Known structural or functional cardiac abnormality, including pulmonary htn. - Glomerular filtration rate < 60 ml/min. - Pregnancy or breastfeeding. - Unable to perform MRI (claustrophobia, unable to fit in magnet,pacemaker,defibrillator or non-MR safe implant). - Hypersensitivity to gadolinium.

Additional Information

Official title Inflammation and the Heart
Principal investigator Charles Michael Stein, MD
Description Aim 1: We want to study people with RA to see if we can detect very early changes in their heart muscle and compare these results to people who do not have RA. Aim 2: We want to study people with RA, who have at least 4 swollen joints, before and 6 months after starting a disease modifying therapy to see if there are any changes in the heart muscle on treatment.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.