METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial)

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Treatments: Folic Acid; Methotrexate; Vitamin B Complex

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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