Comparative Evaluation of Metaprolol Succinate-Dapagliflozin versus Bisoprolol Fumarate-Dapagliflozin on NT-proBNP level in Heart Failure with reduced Ejection Fraction [HFrEF] Patients: A Randomized Open Label Prospective Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To Compare the efficacy of two commonly used Beta blockers (Metoprolol succinate and Bisoprolol fumarate) in combination with Dapagliflozin on NT-proBNP level in improving Left Ventricular Ejection Fraction [LVEF] among Heart Failure with reduced ejection fraction [HFrEF] patients.
研究概览
简要总结
This randomized, open-label, prospective study aims to assess the efficacy of Metoprolol Succinate–Dapagliflozin versus Bisoprolol Fumarate–Dapagliflozin in 60 patients with HFrEF. Patients fulfilling inclusion/exclusion criteria will be recruited and consent obtained. Eligible participants will undergo baseline evaluation, including NT-proBNP levels, ECHO, NYHA class, HbA1C and eGFR level. Patients will then be randomized into two groups (30 each) using block randomization (1:1) and treated for 12 weeks.
Group A: Metoprolol Succinate (12.5-200mg) + Dapagliflozin (10mg) once a day for 12 week
Group B: Bisoprolol Fumarate (1.25-10mg) + Dapagliflozin (10mg) once a day for 12 weeks
Follow-up assessments will include ECHO at week 6 & 12 and NT-proBNP at week 12, along with monitoring of Quality of life and ADR. Finally, data will be statistically analyzed and documented at the end of the study assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient aged 18-80 years with diagnosed HFrEF greater than or equal to 1month, Left ventricular Ejection Fraction lesser than or equal to 40%, NYHA Functional Class II or above, NT-proBNP Level concentration greater than or equal to 600pg/ml, Stable on standard Guideline-directed medical therapy, patient willing and able to provide written informed consent will be included.
排除标准
- •Symptomatic hypotension or Systolic blood pressure less than 95mmHg, Recent diagnosis with Myocardial Infarction, Unstable Angina, stroke or Transient ischemic attack, Patient with Type 1 Diabetes mellitus or Diabetic Keto Acidosis, Previous history of Urinary Tract infection, Lactating and pregnant women, Contraindications to beta blockers or dapagliflozin, eGFR lesser than or equal to 30 mL/min/1.73 m² will be excluded.
结局指标
主要结局
To Compare the efficacy of two commonly used Beta blockers (Metoprolol succinate and Bisoprolol fumarate) in combination with Dapagliflozin on NT-proBNP level in improving Left Ventricular Ejection Fraction [LVEF] among Heart Failure with reduced ejection fraction [HFrEF] patients.
时间窗: ECHO: Week 0, Week 6,Week 12 | NTproBNP: Week 0 and Week 12
次要结局
- To access the quality of life of the patient during the study period using Health Related Quality of Life [HRQOL] Questionnaire, To identify the incidence of adverse events (if any) during the study period, To evaluate treatment adherence and compliance at every follow ups.
研究者
Dr Surya Prakash S
SRM Institute of Science and Technology, Kattankulathur