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临床试验/NCT05689086
NCT05689086招募中不适用

A Virtual Heart Failure Optimization Program for Guideline Directed Medical Therapy and Cardiac Rehabilitation

Cambridge Cardiac Care Centre1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Change from baseline Doses of GDMT

研究概览

简要总结

The goal of this study is to test the impact of a virtual heart failure optimization program on uptake of guideline directed medical therapy, participation in cardiac rehabilitation & impact on echocardiographic parameters.

详细描述

This is a single center, prospective pre-post cohort study testing a virtual, multi-disciplinary heart failure optimization program for up-titration of guideline directed medical therapy. This nurse and kinesiologist-led program will start and up-titrate patients on GDMT and offer virtual cardiac rehabilitation over a 3-month period.

The investigators hypothesize that this program could safely achieve higher rates of maximally tolerated ARNI, Beta-blocker, MRA and SGLT2i rates, as well as participation in cardiac rehabilitation among HFrEF patient participants. The investigators hypothesize that participation will lead to improved Left Ventricular Ejection Fraction on Echocardiogram.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •HFrEF (ejection fraction less than 40%) with New York Heart Association (NYHA) class II or III symptoms
  • •Adults (>18 years of age), capable of providing informed consent, English-proficient and with access to a telephone

排除标准

  • •Patients who are pregnant
  • •Patients who who are incarcerated
  • •Cardiac Transplant Patients
  • •Patients with Left Ventricular Assist Devices

结局指标

主要结局

Change from baseline Doses of GDMT

时间窗: After completion of program (3 months)

Beta-blocker, ACE-inhibitor/Angiotensin receptor blocker/Valsartan-Sacubitril, Mineralocorticoid Receptor Antagonist, SGLT2 inhibitor

Change from baseline Left Ventricular Ejection Fraction

时间窗: After completion of program (3 months)

Measured in Transthoracic Echocardiogram

次要结局

  • Change from baseline NYHA Classification(After completion of program (3 months))
  • Change from baseline Left Ventricular End Systolic Diameter(After completion of program (3 months))
  • Change from baseline Left Ventricular End Diastolic Diameter(After completion of program (3 months))
  • Change from baseline eGFR(After completion of program (3 months))
  • Change from baseline Serum Potassium(After completion of program (3 months))
  • Change from baseline Diastolic Blood Pressure(After completion of program (3 months))
  • Change from baseline Heart Rate(After completion of program (3 months))
  • Change from baseline Body Mass Index(After completion of program (3 months))
  • Change from baseline Left Ventricular Mass Index(After completion of program (3 months))
  • Change from baseline Systolic Blood Pressure(After completion of program (3 months))

研究者

发起方
Cambridge Cardiac Care Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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