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

Phase 2/3 Completed 50 enrolled Instituto de Cardiologia do Rio Grande do Sul

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2007-12
Primary completion: 2008-11
Completion: 2008-11

Outcome

Missed primary endpoint

paper There was no significant difference between groups in distance covered in the 6MWT: the methotrexate group improved by 24.5+/-39.5m, the placebo group by 21.3+/-43.7m (P=.80). PMID 19944358 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methotrexate	Small molecule	7.5 mg	Oral
Background	folic acid	Other / unclassified	5 mg	Oral