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The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.
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 has adenosine-mediated anti-inflammatory effects in rheumatoid arthritis and psoriasis. Methotrexate limits infarct size via this adenosine-dependent mechanisms in heart of dogs (J Cardiovasc Pharmacol. 2004 Apr;43(4):574-9). A recent trial showed that this drug reduced proinflammatory mediators in patients with heart failure (Am Heart J. 2006 Jan;151(1):62-8).
These data suggest that methotrexate may improve physical capacity in patients ischemic heart failure reducing inflammation, but a randomized clinical trial is necessary to prove it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Experimental | 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. |
|
| Placebo | Placebo Comparator | Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos AM Gottschall, MD MSc PhD | Instituto de Cardiologia do Rio Grande do Sul | Study Director |
| Daniel M Moreira, MD | Instituto de Cardiologia do Rio Grande do Sul | Principal Investigator |
| Jefferson L Vieira, MD | Instituto de Cardiologia do Rio Grande do Sul | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia | Porto Alegre | Rio Grande do Sul | 90620001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19944358 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methotrexate | 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. |
| FG001 | Placebo | Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methotrexate | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | meters | Baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methotrexate | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Medeiros Moreira, MD. MSc. | Instituto de Cardiologia do Rio Grande do Sul | 55 (51) 3219-2802 | danielmedeirosmoreira@gmail.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D017202 | Myocardial Ischemia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
|
| Placebo | Drug | 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. |
|
|
| 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 placebo oral plus folic acid 5mg oral once a week for 12 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Improve in Heart Failure Functional Class Measured Using New York Heart Association | Not Posted | 12 weeks |
| Secondary | Improve in Quality of Life Measured Using the Brazilian Edition SF-36 | Not Posted | 12 weeks |
| Secondary | Reduction of Inflammatory Marker Measured Using C-reactive Protein Blood Levels | Not Posted | 12 weeks |
| Secondary | Incidence of All Cause Mortality, Hospitalization for Worsening Heart Failure, Myocardial Infarct, Stroke or Myocardial Revascularization Need | Not Posted | 12 weeks |
| Secondary | Incidence of Adverse Effects of the Treatment | Not Posted | 12 weeks |
| 0 |
| 23 |
| 7 |
| 23 |
| EG001 | Placebo | Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks. | 0 | 24 | 9 | 24 |
| lipothymia | Nervous system disorders | Non-systematic Assessment |
|
| sustained ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |