Chronic Heart Failure
Conditions
Keywords
CHF DM type II
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.
Interventions
DRUGEmpagliflozin 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.
Sponsors
Fazaia Ruth Pfau Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The study will employ a double blind masking approach to ensure unbiased results and mainbtain the integrity of data participants masking; participants will be unaware of whether they are receiving Empagliflozin or placebo investigator masking; healthcare professionals and investigators administering the treatment will not know the treatment assignment.
Intervention model description
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 18 months Setting Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Pakistan
Contacts
Primary ContactTooba Riaz, MBBS
Backup ContactDR Asghar Mehdi, MBBS Phd
Outcome results
None listed