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

Phase 4

Recruiting

• Conditions: Chronic Heart Failure
• Interventions: Drug: Empagliflozin 10 MG

• Registration Number: NCT06706791
• Lead Sponsor: Fazaia Ruth Pfau Medical College

Brief 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.

Detailed Description

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.

This is a comparative clinical study with randomized groups. Participants will be allocated to either the Empagliflozin group or the placebo group alongside standard therapy.

Blinding will be done by assigning drug to participants according to computer generated numbers in 2 groups in 1:1 ratio.

Empagliflozin Group: taking Empagliflozin 10mg once daily per oral along with standard treatment. Their quality of life assessed by using Kansas City Cardiomyopathy questionnaire. Placebo Group: Identical placebo tablets, following the same dose and schedule as the Empagliflozin group along with standard treatment of chronic heart failure.

Duration is of18 months. Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.

Study Timeline

• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental arm, Palcebo controlled group	Empagliflozin 10 MG	Experimental arm, taking empagliflozin 10mg once daily along with standard treatment.
Palcebo controlled group	Empagliflozin 10 MG	Palcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment.

Primary Outcome Measures

Name	Time	Method
improvement in Kansas city cardiomyopathy questionnaire scoring	18 months	Primary outcome measure will be the improvement in quality of life indicating by change in Kansas City cardiomyopathy questionnaire (KCCQ) scoring. higher value indicates better results.

Secondary Outcome Measures

Name	Time	Method
assessment of NT-pro-BNP levels.	18 months	Secondary outcome measures will include the change in NT-pro-BNP levels.lower values indicates better results

Trial Locations

Locations (1)

Fazaia Ruth Pfau Hospital; 🇵🇰 Karachi, Sindh, Pakistan