A Prospective, Randomized, Double-blind, Multicenter Study on the Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,990
- 试验地点
- 1
- 主要终点
- Composite number of hospital admissions for Heart Failure (HF) and all-cause death
研究概览
简要总结
The primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo.
详细描述
Study Description Brief Summary: The primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo.
Detailed Description: Heart failure is one of the most serious health concerns in the world, and it also remains the most common reason for hospitalization in older individuals. In patients with heart failure, anemia is associated with an increased risk of hospitalization and all-cause mortality. The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure (HF) events and cardiovascular death comparing to placebo in patients with reduced ejection fraction on top of standard of care.
This is an investigator-initiated, interventional, prospective, double-blind study. The primary objective is to investigate whether anemia correction is one of the prerequisites and determinants related to the beneficial effects of dapagliflozin in patients with heart failure. Impact of dapagliflozin treatment on hemoglobin level, heart failure-related readmission and all-cause death will be observed in comparison with placebo in heart failure patients receiving guideline recommended standard therapy during the 3months, 6 months and 1 year follow up.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 18 and 100 years.
- •Elevated NT-proBNP or BNP levels on admission.
- •Ejection fraction of 50% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms.
排除标准
- •Treatment with SGLT2-i during the past 3 months of admission,or previous intolerance of an SGLT2 inhibitor.
- •Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization.
- •Pregnant or breast feeding female patients.
研究组 & 干预措施
Dapagliflozin
Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT
干预措施: Dapagliflozin (Drug)
Placebo
Standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT
干预措施: Placebo (Drug)
结局指标
主要结局
Composite number of hospital admissions for Heart Failure (HF) and all-cause death
时间窗: 1 year
Total number of deaths and heart failure hospitalizations in one year
次要结局
- Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score(Baselin, 3 months, 6 months, and 1 year)
- Change in 6-minute walk distance (6MWD)(Baselin, 3 months, 6 months, and 1 year)
- Change in hemoglobin(Baselin, 3 months, 6 months, and 1 year)
研究者
Jianping Zeng
President of Xiangtan Centeral Hospital
Xiangtan Central Hospital