Try our beta test site

RHYTHM (Formerly Escape II Myocardium) (RHYTHM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Columbia University
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Joan M. Bathon, Columbia University
ClinicalTrials.gov Identifier:
NCT01548768
First received: March 6, 2012
Last updated: March 13, 2017
Last verified: March 2017

March 6, 2012
March 13, 2017
October 10, 2011
October 2018   (Final data collection date for primary outcome measure)
  • Change in Left Ventricular mass [ Time Frame: Baseline, 6 months ]
    This is designed to evaluate the differential effect of TNF inhibitors vs triple therapy on Left Ventricular (LV) mass after 6 months of treatment for improvement.
  • Change in Left Ventricular Ejection Fraction [ Time Frame: Baseline, 6 months ]
    This is designed to evaluate Left Ventricular Ejection Fraction (LVEF) for improvement after 6 months of treatment.
  • Improvement of left ventricular mass [ Time Frame: 6 months after treatment with TNF inhibitors versus triple therapy ]
    We will evaluate the differential effect TNF inhibitors vs "triple therapy" on LV mass after 6 months of treatment.
  • Improvement of Left Ventricular Ejection Fraction. [ Time Frame: After 6 months of treatment with TNF inhibitor versus triple therapy ]
Complete list of historical versions of study NCT01548768 on ClinicalTrials.gov Archive Site
Change in the degree of myocardial inflammation [ Time Frame: Baseline, 6 months ]
This is designed to evaluate the degree of myocardial inflammation as indicated by fluorodeoxyglucose (FDG) uptake in positron emission tomography (PET) scan.
Improvement in the degree of myocardial inflammation (as indicated by FDG uptake in PET scanning) [ Time Frame: 6 months after treatment with TNF inhibitor versus triple therapy ]
Not Provided
Not Provided
 
RHYTHM (Formerly Escape II Myocardium)
RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function.

For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects without RA (healthy volunteers) who will function as controls.

For aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to increased RA activity despite their current treatment) will be recruited to continue in the study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care.

The investigators hypothesize that anti-TNF agents in RA patients without heart disease will not adversely affect the heart (will not cause a detrimental change in heart structure or its function).

Patients with Rheumatoid Arthritis (RA) have a shortened life expectancy compared to the general population. Cardiovascular disease (CVD), including heart failure (HF), is the primary cause of the extra deaths in RA. HF, in general, results from failure of the heart muscle to pump adequately. In other words the heart muscle in HF becomes "weak". In patients without RA, the heart muscle gets larger before symptoms of HF appear. Contrary to that, patients with RA have reduced heart size and reduced heart strength. This may mean that in RA the pathway to heart failure may be different compared to what happens in patients without RA. It is possible - for example - that in RA the heart muscle becomes smaller before it becomes weak (while in non-RA patients the heart muscle becomes larger before it becomes weak). It is possible that cells that create inflammation in the joints may also do the same in the heart muscle making it smaller, thinner and eventually weaker.

Patients with RA nowadays can be treated with a variety of medications for their joint inflammation. These medications are powerful and have reduced the risk of permanent joint damage and disability. However it is unknown what is the effect of these medications on the heart size and strength and whether they increase or decrease the risk for cardiovascular disease and heart failure.

Among the medications used for RA are medications called TNF inhibitors. They are usually prescribed to patients who have joint inflammation that has not responded to treatment with the first line medication Methotrexate. Data in non-RA patients with advanced heart failure suggest that anti-TNF agents may not help heart failure and may even be harmful. However, the effect of these agents on the hearts of RA patients has never been directly studied. Some observational studies suggest that RA patients treated with TNF inhibitors have a lower risk of developing heart disease. Overall the knowledge regarding the effect of TNF inhibitors on RA patients heart function is limited.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Rheumatoid Arthritis
  • Drug: TNF inhibitors

    TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.

    The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.

    Other Name: Anti-TNF drugs
  • Drug: DMARDs
    Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.
    Other Name: Disease-modifying antirheumatic drugs
  • Experimental: Patients - DMARDs + TNF Inhibitors
    Patients will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care.
    Interventions:
    • Drug: TNF inhibitors
    • Drug: DMARDs
  • Active Comparator: Patients - DMARDs only
    Patients will receive their current treatment in an open label protocol in the context of standard of care.
    Intervention: Drug: DMARDs
  • No Intervention: Healthy Volunteers
    Subjects without RA who will function as controls.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
175
October 2018
October 2018   (Final data collection date for primary outcome measure)

For RA patients (150 patients):

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 Clinical Disease Activity Index (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
  • Current treatment with "Triple Therapy" or within the last 2 months
  • Untreated positive purified protein derivative (PPD) tuberculosis skin test 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 non-RA subjects (25 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Janine Rose, BS 2123054114 jr2780@cumc.columbia.edu
Contact: Afshin Zartoshti, MS 2123422751 az2200@cumc.columbia.edu
United States
 
 
NCT01548768
AAAI1026
7R01AR050026-07 ( US NIH Grant/Contract Award Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Joan M. Bathon, Columbia University
Columbia University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Joan M Bathon, MD Columbia University
Columbia University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP