Phase 3
Completed N=50
METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial)
Source: ClinicalTrials.gov NCT00759811 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Change in Physical Capacity Measured Using the 6-minute Walk Test Distance — 24.5; 21.3 meters
Summary
The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Physical Capacity Measured Using the 6-minute Walk Test Distance |
24.5; 21.3 | — |
| SECONDARY Improve in Heart Failure Functional Class Measured Using New York Heart Association |
— | — |
| SECONDARY Improve in Quality of Life Measured Using the Brazilian Edition SF-36 |
— | — |
| SECONDARY Reduction of Inflammatory Marker Measured Using C-reactive Protein Blood Levels |
— | — |
| SECONDARY Incidence of All Cause Mortality, Hospitalization for Worsening Heart Failure, Myocardial Infarct, Stroke or Myocardial Revascularization Need |
— | — |
| SECONDARY Incidence of Adverse Effects of the Treatment |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00759811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.