Health Condition 1: null- Suffering from Acute Heart Failure
Conditions
Interventions
Intervention1: Levosimendan: Levosimendan 12-24 mcg/kg/over10 min. bolus, followed by 0.1mcg/kg/min.
continuous infusion which can be decreased to 0.05 or increased to 0.2 mcg/kg /min, [6]
depending o
Sponsors
Department of PharmacologyIPGMERKOLKATA
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients having stage 3 or stage 4 AHF as per Killip classification. 2)Patients of AHF with hypotension. 3)Patients willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients having high output failure. 2)Patients having any type of ongoing ventricular arrhythmia. 3)Patients developing heart failure following rheumatic carditis. 4)Patients developing heart failure consequent to toxic myocarditis. 5)Known patient of hypertrophic obstructive cardiomyopathy(HOCM). 6)Pregnant or nursing women. 7)History of hypersensitivity to study drugs. 8)History of critical illness of other vital organs like liver, kidney or brain marrow. 9)History of major psychiatric illness. 10)History of alcoholism or substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in clinical parametres(orthopnoea, basal crepitations, urine output,systolic blood pressure more than 90 mm of Hg),echocardiographic findings of increase in ejection fraction (EF), and improvement in left ventricular end-diastolic volume (LVEDv) and left ventricular end-diastolic pressure (LVEDp). Reduction in the level of N- Terminal pro B type natriuretic peptide (NT Pro BNP) by the end of one week.Timepoint: At screening, after 24 hours, 1 week and 4 weeks after initiation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in mechanical functions of heart as evidence by echocardiographic findings of increase in ejection fraction (EF), and improvement in left ventricular end-diastolic volume (LVEDv) and left ventricular end-diastolic pressure (LVEDp) at the end of 24 hours, 1 week and 4 weeks respectively from the start of treatment. ï?· Reduction in the level of sensitive heart failure marker N- Terminal pro B type natriuretic peptide (NT Pro BNP) by the end of one week.Timepoint: At screening, after 24 hours, 1 week and 4 weeks after initiation of treatment | — |
Countries
India
Contacts
Public ContactDr Subrata Ray
IPGMER
Outcome results
None listed