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NCT Number: NCT06706791

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

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.

Recruiting

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fazaia Ruth Pfau Hospital

Karachi, Sindh, 75120, Pakistan

Location status: Recruiting

Location contact

Asad Khan, MBBS FCPS

SUB_INVESTIGATOR

Asghar Mehdi, MBBS Phd

SUB_INVESTIGATOR

DR Asghar Mehdi, MBBS Phd

CONTACT

[email protected]

03008228284

Dr Masood Ahmed, MBBS Phd

CONTACT

[email protected]

03002922361

Rubina Khan, MBBS FCP

SUB_INVESTIGATOR

Sadia Khan, MBBS

SUB_INVESTIGATOR

Tooba Riaz, MBBS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Diabetic patient diagnosed (HbA1c > 6.5mg/dl) and currently taking antidiabetic medicine.

Exclusion criteria

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

Treatment and study plan

Empagliflozin 10 MG

Drug

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,

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

DR Asghar Mehdi, MBBS Phd

CONTACT

[email protected]

03008228284 ext. 314

Tooba Riaz, MBBS

CONTACT

[email protected]

03333231665 ext. 316

Sponsors and collaborators

Lead sponsor

Fazaia Ruth Pfau Medical College

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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