Acute Heart Failure
Conditions
Interventions
Trade Name: Preductal MR
Pharmaceutical Form: Tablet
Sponsors
Charles University in Prague, Third Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate possible protective effect of trimetazidin on ischemic myocardium in patients with acute heart failure;Secondary Objective: ;Primary end point(s): Troponin I level | — |
Countries
Czech Republic
Outcome results
None listed