Comparison between Levosimendan with Dobutamine in acute heart failure
Phase 4
- Conditions
- Health Condition 1: null- Suffering from Acute Heart Failure
- Registration Number
- CTRI/2018/08/015293
- Lead Sponsor
- Department of PharmacologyIPGMERKOLKATA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br/ ><br>Reduction in the level of N- Terminal pro B type <br/ ><br>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 Outcome Measures
Name Time Method Improvement in mechanical functions of heart as evidence by echocardiographic <br/ ><br>findings of increase in ejection fraction (EF), and improvement in left ventricular <br/ ><br>end-diastolic volume (LVEDv) and left ventricular end-diastolic pressure (LVEDp) <br/ ><br>at the end of 24 hours, 1 week and 4 weeks respectively from the start of <br/ ><br>treatment. <br/ ><br>ï?· Reduction in the level of sensitive heart failure marker N- Terminal pro B type <br/ ><br>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