MEtabolic Therapy with Trimetazidine in Acute heart failure: an open pilot randomized trial (The METTA – PRAGUE 10 Trial) - METTA - PRAGUE 10

• Conditions: Acute Heart Failure

• Registration Number: EUCTR2007-002893-76-CZ
• Lead Sponsor: Charles University in Prague, Third Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Dyspnea at rest due to acute heart failure (defined as a presence of at least one of the following: S3 gallop OR pulmonary rales OR X-ray prove of pulmonary congestions OR PCW pressure > 25 mmHg).
2.Decreased oxygen saturation (value obtained from pulse oxymetry) within one hour of admission to ICU.
3.Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age less than 18 years.
2.Acute persistent ST-elevation on ECG at admission.
3.Progressive shock (defined as spontaneous systolic blood pressure < 90 mmHg OR systolic blood pressure < 100 mmHg despite dopamin or dobutamin therapy up to 8 µg/kg/min OR any hypotension requiring noradrenalin or adrenalin administration).
4.Patient already on metabolic-modulation therapy.
5.History of allergy to trimetazidine or any additives present in the drug.
6.Inability to ingest oral medication.
7.Unwillingness to be followed for the duration of the study.
8.Women of childbearing potential who are pregnant, nursing or not using effective contraception.
9.Disability of oral drug intake.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified