CTRI/2025/01/079180尚未招募4 期
Efficacy of Dapagliflozin in heart failure with reduced ejection fraction: An observational study
Dr Meghna Bordoloi1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年2月2日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Improvements in cardiometabolic parameters, NYHA class, and echocardiographic measures over the 12-month follow-up period. Furthermore, we expect to observe a reduction in cardiovascular death and recurrent hospitalization rates among patients receiving dapagliflozin therapy. Safety analyses will provide insights into the tolerability and adverse event profile of dapagliflozin in this patient population.
研究概览
简要总结
- Potential participants meeting the eligibility criteria will be identified through screening of patients attending the medicine outpatient department (OPD) and discharged cases from the Medical Intensive Care Unit (MICU) at Acharya Vinobha Bhave Rural Hospital, Sawangi, Meghe. Screening will involve a review of medical records, including recent echocardiography reports, to confirm left ventricular ejection fraction (LVEF) ≤ 45%.
- Upon obtaining informed consent, enrolled patients will undergo baseline assessments, including socio-demographic data collection, anthropometric measurements, evaluation of cardiometabolic risk factors, determination of NYHA class, and baseline 2D echocardiography to measure LVEF.
- Enrolled patients will be initiated on dapagliflozin 10 mg once daily.
- Patients will be scheduled for followup visits at 6-month intervals (i.e., at six months, and twelve months post-baseline). At each followup visit, assessments will be conducted to evaluate the impact of dapagliflozin treatment on various parameters, including cardiometabolic risk factors, NYHA class, echocardiographic measures, and incidence of adverse events.
- The study will be considered complete after the final followup visit at twelve months post-baseline. Data collected will be analyzed to evaluate the efficacy and safety of dapagliflozin in patients with heart failure with reduced ejection fraction.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both genders aged 18 years or older.
- •Diagnosis of ischemic heart disease.
- •Fulfillment of the Framingham criteria for heart failure.
- •Left ventricular ejection fraction (LVEF) documented to be ≤ 45% within the last 1-2 months.
- •Ability and willingness to adhere to SGLT-2 inhibitor therapy.
排除标准
- 未提供
结局指标
主要结局
Improvements in cardiometabolic parameters, NYHA class, and echocardiographic measures over the 12-month follow-up period. Furthermore, we expect to observe a reduction in cardiovascular death and recurrent hospitalization rates among patients receiving dapagliflozin therapy. Safety analyses will provide insights into the tolerability and adverse event profile of dapagliflozin in this patient population.
时间窗: The said outcome will be measured at baseline, 6 months and 12 months
次要结局
- Improvements in KFT and LFT,(Decrease in HBA1C levels,)
研究者
Dr Meghna Bordoloi
Jawaharlal Nehru Medical College, Sawangi (meghe)
研究点 (1)
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