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Dapagliflozin in Acute Heart failure

Phase 4
Conditions
Heart failure with reduced ejection fraction.
Registration Number
IRCT20220529055013N1
Lead Sponsor
Public Sector medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
160
Inclusion Criteria

1. Male/Female patients 30 years and above
2. Diagnosis of acute decompensated heart failure made on admission based on any two of the following signs and symptoms a)Dyspnea at rest or minimal exertion b)Peripheral edema c) Ascites d)5-pound weight gain (rapid) e) Signs of congestion on X-ray
3. Left ventricular Ejection fraction = 40%
4. eGFR = 30ml/min

Exclusion Criteria

Cardiogenic shock;
urgent hospitalization for acute heart failure primarily triggered by pulmonary embolism ,cerebrovascular accident, or acute myocardial infarction
Current hospitalization for acute heart failure not caused primarily by intravascular volume overload
Type 1 Diabetes mellitus
History of Diabetic ketoacidosis
History of hepatic impairment
Known allergy to SGLT 2 inhibitors
Women pregnant or breast feeding

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Effect of drug on kidney function. Timepoint: At day 0, 1, 7 and 30. Method of measurement: estimated glomerular filtration rate ( eGFR).;Improvement in symptoms and quality of life of heart failure patients admitted with acute decompensation. Timepoint: At admission( baseline), followed at Day 1,day7 and day 30. Method of measurement: Kansas city cardiomyopathy questionnaire (KCCQ).
Secondary Outcome Measures
NameTimeMethod
Improvement in Hemoglobin levels. Timepoint: Day 0, 1, 7 and day 30. Method of measurement: complete blood count.;Blood pressure. Timepoint: Day 0,1 7 and 30. Method of measurement: Sphygmamometer.
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