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Clinical Trials/IRCT20230331057788N1
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ational University of Medical Sciences

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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