Safety and Efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1C â?¥ 6.0% or type 2 Diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure.

Torrent Pharmaceutical Ltd0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Salient Inclusion Criteria
•Subjects of either sex, aged >= 45 years.
•Subjects with chronic heart failure, stable for 6 weeks (NYHA class II or III) according to criteria of ESC and on stable medication for heart failure for at least 2 weeks prior to screening.
•Subjects with Type 2 diabetes mellitus (i.e. receiving oral therapy with or without insulin) or an impaired glucose tolerance (HbA1c should be >= 6.0% at screening).
•Subjects with an NT-proBNP >= 400 pg/mL (subjects with atrial fibrillation NT-proBNP >= 1200 pg/mL)
•Subjects receiving at least loop, thiazide or thiazide like diuretic for treating HF
•Subjects able to undergo cardiopulmonary exercise testing

•Salient Exclusion Criteria
•CHF caused by myocarditis, cor pulmonale, congenital heart disease, constrictive pericarditis, or hypertrophic or restrictive cardiomyopathy.
•Acute coronary syndrome or coronary revascularization within 3 months
•Second-degree or third-degree heart block (unless treated with a pacemaker)
•Pulmonary function (FEV1) less than 60 % of predicted or requiring long-term corticosteroids.
•Left ventricular assist device (or an activated minute ventilation pacemaker)
•Uncontrolled hypertension (systolic blood pressure >= 160 mmHg under antihypertensive treatment).
•Glomerular filtration rate (eGFR) 30 ml/min.
•Unwilling or unable to comply with protocol

发起方

Torrent Pharmaceutical Ltd