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

Chronic Heart Failure

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether empagliflozin (a diabetes drug also approved for heart failure) improves quality of life in patients who have both chronic heart failure with reduced pump function and Type 2 diabetes. **You may be eligible if...** - You are between 40 and 70 years old - You have chronic heart failure (NYHA Class II, III, or IV) with a weakened heart pump (ejection fraction less than 40%) - You have Type 2 diabetes (HbA1c above 6.5%) - You are currently on diabetes medication - Your NT-proBNP (a heart stress marker) is above 25 pg/mL **You may NOT be eligible if...** - You are pregnant - You have end-stage kidney disease - You are experiencing acute decompensated (suddenly worsening) heart failure - You are having an acute heart attack (acute coronary syndrome) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.