Efficacy and safety of tolvaptan in Acute Heart Failure
Phase 4
- Conditions
- Health Condition 1: null- Acute Heart Failure
- Registration Number
- CTRI/2013/05/003643
- Lead Sponsor
- SRM Medical College Hospital Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Patients of either gender above 18 years of age
Diagnosis of acute heart failure within 24 hours of presentation to cardio ICU presenting with dyspnea at rest/minimal exertion and at least one of the following
Orthopnea
Peripheral edema
Elevated JVP
Pulmonary rales
Congestion on Chest X-ray
Willing to give informed consent
Exclusion Criteria
Systolic blood pressure < 90 mmHg
Serum sodium >136mEq/L
Serum creatinine > 3 mg/dl
History of acute coronary syndrome in the past 4 weeks
Valvular heart disease
Pregnant women
Breast feeding women
Terminal illness due to other causes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Likert score at end of study period <br/ ><br>Reduction in body weight at end of study period <br/ ><br>Adverse events <br/ ><br> <br/ ><br>Timepoint: 5 days and 30 days
- Secondary Outcome Measures
Name Time Method MortalityTimepoint: 1 month