Impact of Empagliflozin on Quality of Life in Heart Failure Patients with Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effect of Empagliflozin on the quality of life in patients suffering from chronic heart failure and type II diabetes mellitus. It involves a randomized, double-blind, placebo-controlled design where participants are assigned to either the Empagliflozin group or a placebo group, both receiving standard therapy. The study aims to assess quality of life improvements using the Kansas City Cardiomyopathy Questionnaire over an 18-month period, while also evaluating the cost-effectiveness of the treatment in the Pakistani healthcare context.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Fazaia Ruth Pfau Hospital
  Karachi, Sindh, Pakistan Recruiting

Study contacts

• Principal investigator: Tooba Riaz, MBBS — Fazaia Ruth Pfau Medical College
• Study coordinator: Tooba Riaz, MBBS
• Email: drtoobariaz@outlook.com
• Phone: 03333231665

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.