Role of Remogliflozin in patients with Type 2 Diabetes with Acute Heart Failure
- Conditions
- Health Condition 1: E111- Type 2 diabetes mellitus with ketoacidosis
- Registration Number
- CTRI/2021/08/035354
- Lead Sponsor
- Glenmark Pharmaceuiticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
- Systolic blood pressure < 100 mmHg, ongoing therapy with inotropes.
- Cardiogenic Shock
- NYHA class IV
- NT pro BNP > 10,000 pg/ml
- Serum Creatinine > 3.0 mg/dl or EGFR < 30 ml/min/1.73m2
- Signs of active infection.
- Recent Covid-19 infection < 4 weeks.
- Known significant primary Valvular disease.
- Acute HF caused by high rate atrial fibrillation or other significant arrhythmias.
- Acute coronary Syndrome diagnosed < 30 days before study entry.
- Troponin � 5 times the ULN (Upper limit of normality).
- Active Malignancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>The primary endpoint will be- <br/ ><br>�In- hospital development of metabolic acidosis, ketoacidosis <br/ ><br>�In-hospital ketonemia <br/ ><br>�Other adverse events needing drug discontinuation <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 90 Days <br/ ><br>
- Secondary Outcome Measures
Name Time Method Improvement in NYHA ClassTimepoint: �Rate of worsening of heart failure re-hospitalization for HF or death at 90 days. <br/ ><br>�Reduction in NT pro BNP at discharge and at 90 days. <br/ ><br>�Diuretic response weight change during hospitalization. <br/ ><br>�Change in dyspnoea assessed by NYHA class. <br/ ><br>�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. <br/ ><br>