BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Maximum tolerable dose of Entresto achieved
研究概览
简要总结
This study aims to determine if patients with higher BMI can tolerate higher doses of Entresto (sacubitril/valsartan) and experience better symptomatic and functional outcomes compared to patients with lower BMI.
详细描述
This prospective cohort study will enroll heart failure patients with reduced ejection fraction (HFrEF) to evaluate the tolerability and efficacy of Entresto uptitration across different BMI categories (Normal weight, Overweight, Obese, and Very Obese). Primary outcomes include the maximum tolerable dose and incidence of adverse drug reactions. Secondary outcomes include changes in heart failure symptoms, functional capacity measured by the 6-minute walk test, hospitalization rates, and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 and older
- •Diagnosed with heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 35%)
- •Naïve to Entresto therapy or willing to switch from previous ACE inhibitor/ARB therapy
- •Ability to provide informed consent
排除标准
- •Severe renal or hepatic impairment (e.g., eGFR < 30 mL/min/1.73m², severe liver disease)
- •History of angioedema
- •Pregnant or breastfeeding women
- •Patients with malignancies or other severe comorbid conditions
- •Non-compliance with medication regimen
结局指标
主要结局
Maximum tolerable dose of Entresto achieved
时间窗: up to 24 weeks
This outcome measures the highest dose of Entresto that patients in each BMI category can tolerate without experiencing significant adverse drug reactions (ADRs). The dose will be recorded at the end of the titration period, which is expected to last up to 24 weeks.
次要结局
- Changes in Heart Failure Symptoms (NYHA Classification)(up to 24 weeks)
- Changes in Functional Capacity (6-Minute Walk Test Distance)(up to 24 weeks)
- Changes in Quality of Life (KCCQ Score)(up to 24 weeks)
- Changes in BNP/NT-proBNP Levels(up to 24 weeks)
- Hospitalization Rates(up to 24 weeks)
研究者
Ali Aldujeli
Consultant Cardiologist
Lithuanian University of Health Sciences