跳至主要内容
临床试验/NCT05170165
NCT05170165招募中不适用

A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月12日最近更新:
适应症

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raj Khandwalla

Director of Cardiovascular Education, Cedars Sinai Care Foundation

Cedars-Sinai Medical Center

研究点 (1)

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