CLINICAL EFFICACY OF DAPAGLIFLOZIN IN ASSOCIATION WITH GENETIC POLYMORPHISM AND ITS PLASMA LEVELS IN CHRONIC HEART FAILURE PATIENTS

ational University of Medical Sciences0 个研究点目标入组 170 人开始时间: 待定最近更新: 2023年5月1日

适应症

试验速览

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•Pakistani patients of 18 years and above, males and females
•Diagnosed symptomatic heart failure (NYHA class 1–IV)
•Ejection fraction (EF) = 40% on imaging study within last 12 months prior to enrolment
•Patient on stable GDMT of heart failure for =4 weeks
•Both diabetic and non-diabetic patients

•Type-1 diabetics or patients having any history of DKA
•Patients having eGFR = 25 ml/ min/ 1.73 m2 as per (CKD-EPI formula), systolic blood pressure (SBP) < 95 mmHg
•Patients having MI, unstable angina, stroke, acute heart failure (HF) or any hospitalization due to acute HF <4 weeks preceding enrolment
•Patients undergoing PCI /CABG or valvular replacement, any previous transplantation of heart or infixing of ventricular assistance device (VAD), implantation of Cardiac resynchronization therapy (CRT) within 3 months preceding enrolment or any plan to undergo after randomization
•Patients having active myocarditis, uncorrected primary valvular disease, restrictive or hypertrophic (obstructive) cardiomyopathy; bradycardia, 2nd or 3rd degree heart block without having any pacemaker
•Patients received any SGLT2i within 12 weeks preceding screening visit or hypersensitivity to Dapagliflozin
•Pregnant ladies and nursing mothers, severe COPD leading to dyspnea, any malignancy or hepatic impairment

发起方

ational University of Medical Sciences