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

NCT00759811 | Completed Phase 2 Results DMC

• 1 other identifier: UP4062
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Myocardial Ischemia

Keywords

Heart Failure; Myocardial Ischemia; Methotrexate; Inflammation; Anti-Inflammatory Agents; Inflammation Mediators

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

Drug: Methotrexate

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.

Drug: Placebo

Interventions

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.

Also known as: Rheumatrex, Trexall

Methotrexate

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.

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, 90620001, Brazil

Location

Related Publications (1)

• 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.

  PMID: 19944358 RESULT

MeSH Terms

Conditions

Heart Failure; Myocardial Ischemia; Inflammation

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Daniel Medeiros Moreira, MD. MSc.
• Organization: Instituto de Cardiologia do Rio Grande do Sul

danielmedeirosmoreira@gmail.com

55 (51) 3219-2802

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: December 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 8, 2013
• Results First Posted: May 8, 2013

Record last verified: 2013-03

Locations

BR (1)