Trial Outcomes & Findings for METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial) (NCT NCT00759811)

Results Overview

The primary outcome of the study was the difference in 6MWT distance before and after the treatment (change in meters evaluated by t test).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2013-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Placebo Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
Overall Study STARTED	25	25
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methotrexate n=25 Participants 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 n=25 Participants Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=99 Participants	18 Participants n=107 Participants	34 Participants n=206 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants	7 Participants n=107 Participants	16 Participants n=206 Participants
Age Continuous	60.8 years STANDARD_DEVIATION 10.3 • n=99 Participants	58.2 years STANDARD_DEVIATION 8.0 • n=107 Participants	59.5 years STANDARD_DEVIATION 9.2 • n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	18 Participants n=99 Participants	21 Participants n=107 Participants	39 Participants n=206 Participants
Region of Enrollment Brazil	25 participants n=99 Participants	25 participants n=107 Participants	50 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

The primary outcome of the study was the difference in 6MWT distance before and after the treatment (change in meters evaluated by t test).

Outcome measures

Outcome measures
Measure	Methotrexate n=25 Participants 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 n=25 Participants Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
Change in Physical Capacity Measured Using the 6-minute Walk Test Distance	24.5 meters Standard Deviation 39.5	21.3 meters Standard Deviation 43.7

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Methotrexate

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Methotrexate n=23 participants at risk 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 n=24 participants at risk Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
Gastrointestinal disorders nausea	8.7% 2/23	8.3% 2/24
Nervous system disorders lipothymia	4.3% 1/23	8.3% 2/24
Cardiac disorders sustained ventricular tachycardia	4.3% 1/23	0.00% 0/24
Nervous system disorders dizziness	13.0% 3/23	20.8% 5/24

Additional Information

Daniel Medeiros Moreira, MD. MSc.

Instituto de Cardiologia do Rio Grande do Sul

Phone: 55 (51) 3219-2802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place