Health Condition 1: I95-I99- Other and unspecified disorders of the circulatory system Health Condition 2: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: dapagliflozin: Participants in the intervention group will receive tablet dapagliflozin 10 mg orally once daily, starting within 24 hours of hospital admission, in addition to standardi
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: patients present to the medical emergency with acute heart failure NYHA III or IV, with a systolic blood pressure above 100 mmHg, with the following Any one of the following clinical features- elevated JVP, ascites, pedal edema, crackles on auscultation, weight gain of more than 2 kgs over the last 3 days Chest x-ray is suggestive of volume overload, that is, venous cephalization, Kerley B lines, bat-wing patterns, and pleural effusion BNP more than 100 ng per lt or NT-pro-BNP more than 300 ng per lt
Exclusion criteria
Exclusion criteria: Type 1 diabetes mellitus Cardiogenic shock (MAP less than 60 mmHg or requiring vasopressor support to maintain MAP or lactate more than 4) History of acute coronary syndrome in the past 30 days (ST elevation or depression more than 1 mm in more than 2 consecutive leads with Trop-I more than 40 ng per L) End-stage renal disease with eGFR of less than 30 ml/min/1.73m2 Chronic liver disease Chronic lung disease (COPD and ILD) COVID-19 Positive patients Non-cardiogenic dyspnea Patient taking any SGLT2i as an outpatient chronic therapy Pregnant or lactating woman Heart failure due to chemotherapy or radiation toxicity The patient had any cardiac surgery or intracardiac implantation or pacemakers, or ventricular assist devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effectiveness of dapagliflozin as a treatment for acute heart failure in reducing the combined primary endpoint: a composite of 30-day all-cause mortality and 30-day re-admission in patients presenting to the medical emergencyTimepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of dapagliflozin in reducing the length of hospital stay. To evaluate the effect of dapagliflozin on the symptomatic relief of acute heart failure, particularly focusing on the severity of dyspnea as assessed by the dyspnea visual analogue scale between day 1 and day 5. To assess the impact of dapagliflozin on percent changes in pro-BNP levels at admission and on the fifth day or at discharge. To evaluate the diuretic efficiency of dapagliflozin expressed in terms of the requirement of the cumulative dose of loop diuretics. To assess the adverse effects of dapagliflozin over standard treatment in acute heart failure Timepoint: Day 5 or at discharge | — |
Countries
India
Contacts
Public ContactDr Saurabh C Sharda
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed