RecruitingPhase 4NCT06706791

Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II


Sponsor

Fazaia Ruth Pfau Medical College

Enrollment

156 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Effect of Empagliflozin on Quality of Life in patient of Chronic Heart Failure with Diabetes Mellitus Type II. As per ESC Guidelines Empagliflozin is recommended as part of the first-line treatment for HFrEF, irrespective of diabetes status. As per American College of Cardiology (ACC)/American Heart Association (AHA) Empagliflozin is recommended in both diabetic and non-diabetic HF (especially beneficial in patients with HFrEF and HFpEF). The aim of my study is to assess the impact of Empagliflozin on quality of life in Pakistani patients, considering the genetic, environmental and cultural factors. The study will also explore whether Empagliflozin can offer cost-effective option for managing chronic heart failure and diabetes, potentially reducing the economic burden on both patients and health care system.


Eligibility

Min Age: 40 YearsMax Age: 70 Years

Inclusion Criteria5

  • Age 40-70 years at time of screening.
  • Both Men and women are included in study.
  • Patients with chronic heart failure and currently categorized in class II-IV heart failure as per NHYA classification having ejection fraction less than 40%.
  • Patients having NT- proBNP levels greater than 25pg/ml.
  • Diabetic patient diagnosed (HbA1c \> 6.5mg/dl) and currently taking antidiabetic medicine.

Exclusion Criteria4

  • Pregnant female.
  • Patient with end stage renal disease (ESRD).
  • Patient with acute decompensated heart failure.
  • Acute coronary syndrome patients.

Interventions

DRUGEmpagliflozin 10 MG

participants will be divided in two groups one group will empagliflozin 10mg once daily along with standard treatment secong group receiving placebo once daily along with standard treatment.


Locations(1)

Fazaia Ruth Pfau Hospital

Karachi, Sindh, Pakistan

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NCT06706791


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