Impact of Empagliflozin on Quality of Life in Heart Failure Patients with Diabetes
Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II
This study is testing if the medication Empagliflozin can improve the quality of life for people with both chronic heart failure and type II diabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Fazaia Ruth Pfau Medical College Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06706791 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 40-70 with chronic heart failure classified as NYHA class II-IV and type II diabetes.
Not a fit: Patients with end-stage renal disease, acute decompensated heart failure, or acute coronary syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for patients with chronic heart failure and diabetes, providing a new effective treatment option.
How similar studies have performed: Previous studies have shown positive outcomes with Empagliflozin in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Karachi, Sindh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.