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临床试验 NCT07489352 针对心力衰竭，Beta-blocker，老年人目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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N-of-1 Trial to Promote Beta-Blocker Titration in Heart Failure 50 随机化 适应性设计 交叉设计 剂量递增

尚未招募
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临床试验NCT07489352是一项针对心力衰竭，Beta-blocker，老年人的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年5月5日开始，预计招募50名患者。该研究由布莱根妇女医院主导，计划于2027年3月5日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月24日。
简要概括
In this study we seek to understand whether N-of-1 trials using a crossover withdrawal/reversal design with as many 2-week periods can be used to identify the highest tolerated beta-blocker dose for patients with Heart Failure with Reduced Ejection Fraction (HFrEF). To achieve this objective we will conduct a 2-arm randomized controlled trial of 50 participants, comparing intervention(N-of-1 trials) to enhanced usual...显示更多
官方标题

N-of-1 Trials to Promote Patient-Centered Beta-Blocker Titration in Heart Failure With Reduced Ejection Fraction

疾病
心力衰竭Beta-blocker老年人
其他研究标识符
NCT编号
NCT07489352
实际开始日期
2026-05-05
最近更新发布
2026-03-24
预计完成日期
2027-03-05
计划入组人数
50
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Guideline-directed medical therapy
N-of-1 trials
主要目的
卫生服务研究
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性N-of-1 Trials
N-of-1 trials using a crossover withdrawal/reversal design will allow for as many 2-week periods as needed to identify the highest tolerated beta-blocker dose
N-of-1 trials
N-of-1 trials using a crossover withdrawal/reversal design will allow for as many 2-week periods as needed to identify the highest tolerated beta-blocker dose
阳性对照Enhanced usual care
We will compare the intervention to an "enhanced usual care." Our study team will not provide guidance for dose titration (this will be at physician and patient discretion); and participants will not have access to PROs or the data visualization tool. Since attention can affect outcomes, we will "enhance usual care" by conducting phone calls at the same frequency as the intervention group.
增强的常规护理
We will compare the intervention to an "enhanced usual care." Our study team will not provide guidance for dose titration (this will be at physician and patient discretion); and participants will not have access to PROs or the data visualization tool. Since attention can affect outcomes, we will "enhance usual care" by conducting phone calls at the same frequency as the intervention group.
主要终点
结果指标度量标准描述时间框架
Maximum beta-blocker dose achieved
Our primary endpoint is the maximum beta-blocker dose achieved, in proportion to target dose.
120 days
次要终点
结果指标度量标准描述时间框架
Proportion of participants taking >50% of target dose
The secondary outcome will be the proportion of participants taking at least \>50% of target beta-blocker dose.
120 days
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
60 Years
适龄性别
全部
  • Adults aged ≥60 years
  • Diagnosed with HFrEF (LVEF <40%)
  • Taking below 50% of guideline-based target β-blocker dose (guideline-based target doses: metoprolol 200mg daily; carvedilol 25mg BID; bisoprolol 10mg daily)

  • Contraindication to beta-blocker including allergy
  • Treating physician disapproval of enrollment
  • Clinical instability
Brigham and Women's Hospital logo布莱根妇女医院398 个活跃的临床试验可供探索
  • National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
  • Weill Medical College of Cornell University logoWeill Medical College of Cornell University
研究责任方
Julie Lauffenburger, 主要研究者, Associate Professor, Brigham and Women's Hospital
研究中心联系人
联系人: Parag Goyal, MD, MSc, (646) 962-7571, [email protected]
联系人: Julie Lauffenburger, PharmD, PhD, [email protected]
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