A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients at or above 50% target dose of GDMT in HFrEF patients
研究概览
简要总结
The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).
详细描述
The purpose of our study is to test whether home blood pressure monitoring (HBPM) with clinical-decision support (CDS) will optimize the use of GDMT in patients with HFrEF. HBPM allows cardiologists and NPs to monitor patients outside the clinical setting so that GDMT can be safely initiated and up-titrated. The CDS employs HBPM and electronic medical record (EMR) data to implement the ACC/AHA HF guidelines and provides cardiologists and NPs with GDMT recommendations.
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
- •Diagnosis of HFrEF (left ejection fraction < 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
- •New York Heart Association (NYHA) class II-III at most recent screening assessment.
- •GDMT composite score of less than or equal to 50% at baseline
排除标准
- •Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
- •Baseline creatinine > 2 mg/dl or potassium level at baseline > 5 mEq/L or eGFR <30 mL/min/1.73 m
- •Baseline systolic blood pressure < 100 mmHg.
- •Concomitant use of ACE, ARB, and/or ARNI
- •Polycystic kidney disease
- •History of angioedema
- •History of or currently on a transplant list
- •Left ventricular assist device
- •Uncontrolled asthma
- •Severe COPD
- •Cirrhosis
- •Currently receiving hospice or comfort care
- •Patient not proficient with written and spoken English
- •Patient has diminished decision making capability
- •History of non-compliance
结局指标
主要结局
Proportion of patients at or above 50% target dose of GDMT in HFrEF patients
时间窗: 6 months
Change in the proportion of patients at or above 50% target dose of GDMT in
次要结局
- Percentage of accepted medication recommendations(6 months)
研究者
Raj Khandwalla
Director of Cardiovascular Education, Cedars Sinai Care Foundation
Cedars-Sinai Medical Center
