Status:
COMPLETED
METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial)
Lead Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Conditions:
Heart Failure
Myocardial Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.
Detailed Description
Recent studies have showed the importance of proinflammatory mediators in the heart failure. However, there is a lack of benefit of therapies that tried to neutralize these mediators. Methotrexate ha...
Eligibility Criteria
Inclusion
- Heart failure functional class measured using the New York Heart Association classification class II, III or IV
- Left ventricular fraction \<0.45 at the ventriculography
- Angiographic coronary lesions higher than 50% or coronary lesion revascularized (coronary artery bypass or percutaneous transluminal coronary angioplasty)
Exclusion
- Myocardial infarction in the past four months
- Coronary artery bypass or percutaneous transluminal coronary angioplasty in the past four months
- Left ventricular disfunction diagnosed during a acute coronary syndrome
- Those who require revascularization in the following 12 weeks
- Hepatic disease (ALT and AST higher than the upper limit of the reference value)
- Renal failure (plasma creatinine higher than 2.0mg/dl)
- Alcoholism (20 doses per week or more)
- Illegal drug use
- Rheumatoid arthritis or other inflammatory diseases
- Infectious disease
- Neoplasm
- Anemia (hematocrit lower than 30%)
- Currently on any anti-inflammatory drugs
- Difficulty in walking
- Unable to understand/complete the 36-item Short Form health survey (SF-36)
- Those who do not give informed consent
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00759811
Start Date
December 1 2007
End Date
November 1 2008
Last Update
May 8 2013
Active Locations (1)
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1
Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, Brazil, 90620001