RHYTHM (Formerly Escape II Myocardium)

Description

Data on a small number of patients with Rheumatoid Arthritis (RA) show that patients with RA may have a smaller heart size and altered heart function. There is limited evidence that general inflammation due to RA and inflammation within the heart may lead to a smaller heart size which may precede heart failure in RA. Preliminary data show that all these may improve with treatment with a specific class of medications called Tumor Necrosis Factor (TNF) inhibitors. The investigators hypothesize that RA affects the size and function of the heart via inflammation and that treatment with TNF inhibitors may improve the heart size and function and possibly prevent the development of heart failure in RA.

In order to investigate these hypotheses the investigators are going to identify 50 patients who have joint inflammation that has not responded to treatment with methotrexate. As it would happen under standard of care (even without participation in the study) these patients will receive additional treatment to control their joint disease. The investigators will randomly assign these patients to receive one of two equivalent treatments that are commonly prescribed in clinical practice and in the context of standard of care: either a TNF inhibitor OR the medications sulfasalazine and hydroxychloroquine will be added to methotrexate after randomization. It is known that these two different treatments are equivalent in controlling joint inflammation but is not known if one or the other has a more favorable effect on the heart size and function. The patients will be evaluated at baseline and return 6 months after randomization and will have imaging of their heart with PET scanning and echocardiogram at both time points. Participants will also provide information about their RA, other diseases and will offer blood for testing. The investigators assume (hypothesize) that patients randomly assigned to TNF inhibitor will have improved heart size and better heart function and less inflammation in the heart compared to patients assigned to take the oral medications sulfasalazine and hydroxychloroquine.

Study Start Date

October 2011

Estimated Completion Date

October 2016

Interventions

  • Drug: TNF inhibitors
  • Drug: Triple Therapy

Specialties

  • Cardiology: Clinical Pharmacology,Myocardium/Pericardium
  • Internal Medicine: Cardiology,Clinical Pharmacology,Rheumatology
  • Rheumatology: Clinical Pharmacology,Rheumatoid Arthritis
  • Pharmacy: Drug Trials

MeSH Terms

  • Arthritis, Rheumatoid
  • Heart Diseases

Study ID

Columbia University -- AAAI1026

Status

Unknown

Trial ID

NCT01548768

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

25

Sponsor

Columbia University

INCLUSION CRITERIA
  • Diagnosis of Rheumatoid Arthritis by 2010 American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) diagnostic criteria
  • Age>18 years old
  • Moderate to high RA disease activity defined by a CDAI of >10
  • Stable dose of Methotrexate for 6 weeks prior to enrollment?
  • Stable doses of Nonsteroidal anti-inflammatory drug (NSAID) and prednisone (if already taking these medications) for 2 weeks prior to study EXCLUSION CRITERIA
  • Prior self reported or physician diagnosed CV event (MI? angina? stroke or Transient Ischemic Attach (TIA)? Heart Failure (HF)? prior CV procedure (e.g., coronary artery bypass graft, angioplasty, valve replacement, pacemaker)?
  • Contraindications to having a PET-CT scan or receive adenosine or Fludeoxyglucose (FDG).
  • Active treatment for Cancer
  • Uncontrolled hypertension
  • Diabetes
  • Smoking
  • Treatment with a TNF inhibitor or other biologic currently or within the last 6 months
  • Treatment with any non-biologic disease-modifying antirheumatic drug (DMARD) other than MTX in the past two months?
  • Untreated positive (tuberculosis skin test) PPD or active tuberculosis
  • History of Lymphoma and Melanoma
  • Ejection Fraction (EF) < 40% (if not known in advance then the Study Visit I Echocardiogram results will be used to exclude the patient from randomization and follow up)
  • Change in NSAID/Prednisone dosage in last 2 weeks
  • Participation in other research studies involving imaging/radiation exposure For control participation (15 controls): INCLUSION CRITERIA
  • Age>18 years old
  • Absence of diagnosis of RA. EXCLUSION CRITERIA
  • Prior self reported or physician diagnosed CV event (MI? angina? stroke or Transient Ischemic Attach (TIA)? Heart Failure (HF)? prior CV procedure (e.g., coronary artery bypass graft, angioplasty, valve replacement, pacemaker)?
  • Contraindications to having a PET-CT scan or receive adenosine or FDG.
  • Uncontrolled hypertension.
  • Participation in other research studies involving imaging/radiation exposure
  • Gender

    Both

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    Accepts Healthy Volunteers

    Study Locations and Contact Information (1)

    Study Location Distance Name Phone Email
    Columbia University Medical Center - New York, New York 44.8 miles Janine Rose 212-305-4114 jr2780@cumc.columbia.edu

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