IRCT20230331057788N1
Recruiting
Phase 4
CLINICAL EFFICACY OF DAPAGLIFLOZIN IN ASSOCIATION WITH GENETIC POLYMORPHISM AND ITS PLASMA LEVELS IN CHRONIC HEART FAILURE PATIENTS
ational University of Medical Sciences0 sites170 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure.
- Sponsor
- ational University of Medical Sciences
- Enrollment
- 170
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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