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

Sponsor
Fazaia Ruth Pfau Medical College
Study ID
NCT06706791
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Heart Failure

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Mar 2025
Primary completion
Jun 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: experimental arm, Palcebo controlled group
    Experimental arm, taking empagliflozin 10mg once daily along with standard treatment.
  • Placebo Comparator: Palcebo controlled group
    Palcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment.

Primary Outcome Measure

improvement in Kansas city cardiomyopathy questionnaire scoring [ Time Frame: 18 months ]

Central Contacts

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