Remogliflozin in patients with type 2 diabetes hospitalized for acute decompensated heart failure - Remo Safe-AHF Study

Glenmark Pharmaceuiticals0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•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 Ã¢â?°Â¥ 1,400 pg/ml in patients with sinus rhythm.
•d. NT-pro BNP Ã¢â?°Â¥ 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 Ã¢â?°Â¥ 5 times the ULN (Upper limit of normality).
•- Active Malignancy.

发起方

Glenmark Pharmaceuiticals