NCT00759811|CompletedPhase 2/3ResultsDMC
METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial)
METIS
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Sponsor study identifier
interventional
50
1 country
1
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
September 24, 2008
Actual (reported)September 25, 2008
Actual (reported)November 2008
Actual (reported)November 2008
Actual (reported)May 8, 2013
Actual (reported)Change in Physical Capacity Measured Using the 6-minute Walk Test Distance
The primary outcome of the study was the difference in 6MWT distance before and after the treatment (change in meters evaluated by t test).
Baseline and 12 weeks
Improve in Heart Failure Functional Class Measured Using New York Heart Association
12 weeks
Improve in Quality of Life Measured Using the Brazilian Edition SF-36
12 weeks
Reduction of Inflammatory Marker Measured Using C-reactive Protein Blood Levels
12 weeks
Incidence of All Cause Mortality, Hospitalization for Worsening Heart Failure, Myocardial Infarct, Stroke or Myocardial Revascularization Need
12 weeks
Incidence of Adverse Effects of the Treatment
12 weeks
Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks. All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks.
Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620001, Brazil
Moreira DM, Vieira JL, Gottschall CA. The effects of METhotrexate therapy on the physical capacity of patients with ISchemic heart failure: a randomized double-blind, placebo-controlled trial (METIS trial). J Card Fail. 2009 Dec;15(10):828-34. doi: 10.1016/j.cardfail.2009.06.439. Epub 2009 Aug 5.
Carlos AM Gottschall, MD MSc PhD
Instituto de Cardiologia do Rio Grande do Sul
Daniel M Moreira, MD
Instituto de Cardiologia do Rio Grande do Sul
Jefferson L Vieira, MD
Instituto de Cardiologia do Rio Grande do Sul
50 participants (actual enrollment reported by the registry).
First Submitted
September 24, 2008
First Posted
September 25, 2008
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure
Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks. All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)Last Updated
May 8, 2013
Results First Posted
May 8, 2013
Record last verified: 2013-03
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Source: ClinicalTrials.gov.
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