Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- improvement in Kansas city cardiomyopathy questionnaire scoring
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant female.
- •Patient with end stage renal disease (ESRD).
- •Patient with acute decompensated heart failure.
- •Acute coronary syndrome patients.
研究组 & 干预措施
experimental arm, Palcebo controlled group
Experimental arm, taking empagliflozin 10mg once daily along with standard treatment.
干预措施: Empagliflozin 10 MG (Drug)
Palcebo controlled group
Palcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment.
干预措施: Empagliflozin 10 MG (Drug)
结局指标
主要结局
improvement in Kansas city cardiomyopathy questionnaire scoring
时间窗: 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.
次要结局
- assessment of NT-pro-BNP levels.(18 months)
研究者
Tooba Riaz
clinical reseacher resident in FCPS Pharmacology
Fazaia Ruth Pfau Medical College