Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in KCCQ-23 score
研究概览
简要总结
This is a prospective pilot study to evaluate changes before and 4 weeks after beta-blocker withdrawal in 30 HFpEF patients.
详细描述
This is a prospective pilot study to evaluate changes before and 4 weeks(+/- 1 week) after beta-blocker withdrawal in 30 HFpEF patients. The study involves 2 visits that are 4 weeks apart. The first study visit will occur at a standard of care clinic visit and the second visit will be a research visit to fill out questionnaires and perform the limited echocardiogram. No long term follow up beyond the 2nd visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable HFpEF patients with NYHA Class II-III or elevated BNP ≥100
- •N=30 (Target: 30).
- •Age: 50 ~ 80 years.
- •ECHO evidence of EF ≥50% and Grade 2 or 3 diastolic dysfunction.
- •Chronic loop diuretic use
- •Currently on beta-blocker
排除标准
- •Beta blocker was prescribed for treating other cardiac conditions such as atrial fibrillation or coronary artery disease.
- •Heart rate > 100 bpm
- •Recent hospitalization due to HF within 3 months
- •Non-English speaker
结局指标
主要结局
Changes in KCCQ-23 score
时间窗: Baseline and after 4 weeks of beta blocker discontinuation
Kansa city cardiomyopathy questionnaire (KCCQ-23)- self-administered, 23-item. questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. Scores are transformed to a range of 0-100, where higher scores reflect better health status.
次要结局
- Changes in cardiac mechanics by echocardiography(Baseline and after 4 weeks of beta blocker discontinuation)
- Changes in biomarker(Baseline and after 4 weeks of beta blocker discontinuation)
- 6 minute walk test(Baseline and after 4 weeks of beta blocker discontinuation)
研究者
Christopher Pickett
Associate Professor
UConn Health