Recruiting

Empagliflozin's Impact on Quality of Life in Chronic Heart Failure with Type II Diabetes

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What is being tested

Empagliflozin 10 MG

Drug
Who is being recruted

From 40 to 70 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorFazaia Ruth Pfau Medical College
Study ContactTooba Riaz, MBBSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2025

Actual date on which the first participant was enrolled.

This study aims to explore how the medication Empagliflozin affects the quality of life in people suffering from chronic heart failure who also have Type II diabetes. Empagliflozin is already recommended for treating a type of heart failure called HFrEF, regardless of whether the patient has diabetes. By understanding its impact on quality of life, especially for those with concurrent heart failure and diabetes, this study hopes to improve treatment strategies and overall patient well-being. Participants in the study are divided into two groups by chance: one receives the actual medication, Empagliflozin, and the other receives a placebo, which is a look-alike pill with no active ingredient. Both groups will continue their usual heart failure treatments. The medication or placebo is taken orally once daily for 18 months. To assess any changes, researchers will use a specific questionnaire designed to measure the quality of life in heart failure patients. This study is being conducted at Fazaia Ruth Pfau Medical College and Hospital and NICVD Hospital in Karachi.

Official TitleEffect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II
NCT06706791
Principal SponsorFazaia Ruth Pfau Medical College
Study ContactTooba Riaz, MBBSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

156 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
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.
Show More Criteria
4 exclusion criteria prevent from participating
Pregnant female.
Patient with end stage renal disease (ESRD).
Patient with acute decompensated heart failure.
Acute coronary syndrome patients.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Palcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment.

Group II

Experimental
Experimental arm, taking empagliflozin 10mg once daily along with standard treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fazaia Ruth Pfau Hospital

Karachi, PakistanOpen Fazaia Ruth Pfau Hospital in Google Maps
Recruiting
One Study Center
Empagliflozin's Impact on Quality of Life in Chronic Heart Failure with Type II Diabetes | PatLynk