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

March 19, 2025 updated by: Tooba Riaz, Fazaia Ruth Pfau Medical College

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75120
        • Recruiting
        • Fazaia Ruth Pfau Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tooba Riaz, MBBS
        • Sub-Investigator:
          • Asghar Mehdi, MBBS Phd
        • Sub-Investigator:
          • Sadia Khan, MBBS
        • Sub-Investigator:
          • Asad Khan, MBBS FCPS
        • Sub-Investigator:
          • Rubina Khan, MBBS FCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm, Palcebo controlled group
Experimental arm, taking empagliflozin 10mg once daily along with standard treatment.
Drug: Empagliflozin 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.
Other Names:
  • Horizon,
Placebo Comparator: Palcebo controlled group
Palcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment.
Drug: Empagliflozin 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.
Other Names:
  • Horizon,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in Kansas city cardiomyopathy questionnaire scoring
Time Frame: 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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of NT-pro-BNP levels.
Time Frame: 18 months
Secondary outcome measures will include the change in NT-pro-BNP levels.lower values indicates better results
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fazaia Ruth Pfau Medical College

Investigators

  • Principal Investigator: Tooba Riaz, MBBS, Fazaia Ruth Pfau Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRPMC-IRB-2024-64
  • FMC,Air university (Other Identifier: Air university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

it will be shared if required by relevent authorities

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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