Health Condition 1: E111- Type 2 diabetes mellitus with ketoacidosis
Conditions
Interventions
Intervention1: Drug Dispensation: Tab Remogliflozin Verses Standard care of treatment in patients with type 2 Diabetes and acute heart failure
Control Intervention1: SGLT2 inhibitor: Type 2 Diabetes M
Sponsors
Glenmark Pharmaceuiticals
Eligibility
Inclusion criteria
Inclusion criteria: - Age above 18 years - and below 65 years - Patients with type-2 diabetes mellitus admitted to the hospital for acute HF. - Type 2 diabetes is defined as patient who had been diagnosed previously as type 2 diabetes and is already on oral hypoglycaemic drugs and whose plasma glucose level on admission is between 120 and 350 mg/dl irrespective of their HBA1C level. - Acute HF is defined as including all of the following, measured at any time between presentation (including the emergency department [ED]) and randomization: a. Dyspnoea at rest or with minimal exertion. b. Pulmonary congestion, clinically detected and/or on chest X-ray. c. NT-pro BNP � 1,400 pg/ml in patients with sinus rhythm. d. NT-pro BNP � 2000 pg/ml in patients with atrial fibrillation. - Able to start the administration of an SGLT2 inhibitor within 24 hrs. of presentation to the hospital (ED or cardiology/ internal medicine ward). - Able to provide written informed consent. - Not exposed to SGLT2 inhibitors in previous 30 days.
Exclusion criteria
Exclusion criteria: - Systolic blood pressure - Cardiogenic Shock - NYHA class IV - NT pro BNP > 10,000 pg/ml - Serum Creatinine > 3.0 mg/dl or EGFR - Signs of active infection. - Recent Covid-19 infection - Known significant primary Valvular disease. - Acute HF caused by high rate atrial fibrillation or other significant arrhythmias. - Acute coronary Syndrome diagnosed - Troponin � 5 times the ULN (Upper limit of normality). - Active Malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be assessed by comparing the SGLT2 group to the group of patients allocated to placebo with regard to development of ketosis as well as the frequency of serious adverse events. The primary endpoint will be- ââ?¬Â¢ In- hospital development of metabolic acidosis, ketoacidosis ââ?¬Â¢ In-hospital ketonemia ââ?¬Â¢ Other adverse events needing drug discontinuation Timepoint: 90 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in NYHA ClassTimepoint: ââ?¬Â¢ Rate of worsening of heart failure re-hospitalization for HF or death at 90 days. ââ?¬Â¢ Reduction in NT pro BNP at discharge and at 90 days. ââ?¬Â¢ Diuretic response weight change during hospitalization. ââ?¬Â¢ Change in dyspnoea assessed by NYHA class. ââ?¬Â¢ Worsening renal function defined as proportion of patients percentage with a further increase of more than 0.3 mg per dl in serum creatinine at day 3 compared to baseline and at end of follow up for 90 days. | — |
Countries
India
Contacts
Public ContactDr Pallavi Bhaskarwar
Spandan Heart Institute and Research Centre India Pvt Ltd
Outcome results
None listed