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Intermediate Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy

2026年9月26日更新者：Karim Atef Ali Ahmed、Assiut University

Intermediate Outcomes of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) in View of Current Guideline-Directed Medical Therapy

This prospective observational study aims to evaluate intermediate clinical, renal, and functional outcomes in patients with heart failure with reduced ejection fraction treated with contemporary guideline-directed medical therapy over a 6 to 12 month follow-up period.

研究概览

地位

尚未招聘

条件

详细说明

Guideline-directed medical therapy (GDMT) is the cornerstone of treatment for heart failure with reduced ejection fraction. This observational study will enroll adult patients with chronic HFrEF (LVEF ≤ 40%) who are stable on or planned to initiate GDMT.

Patients will be followed for 6 to 12 months to assess changes in renal function, functional status, quality of life, left ventricular ejection fraction, hospitalization rates, and medication adherence.

研究类型

观察性的

注册 (估计的)

250

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Karim A Ali, Resident
电话号码：+20 10 69625533
邮箱：kbs621304@gmail.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult patients with chronic heart failure with reduced ejection fraction attending the Cardiovascular Department at Assiut University.

描述

Inclusion Criteria:

Age 18 years or older
Diagnosis of chronic HFrEF with LVEF ≤ 40% documented by echocardiography
Stable on or planned initiation of guideline-directed medical therapy
Ability to provide informed consent

Exclusion Criteria:

- Acute decompensated heart failure requiring intravenous inotropes at enrollment
End-stage renal disease on dialysis
eGFR less than 20 mL/min/1.73 m² at baseline
Severe primary valvular disease requiring immediate intervention
Life expectancy less than 6 months due to non-cardiac illness

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
Single cohort: HFrEF patients on GDMT Adult patients with heart failure with reduced ejection fraction who are receiving or planned to receive contemporary guideline-directed medical therapy and will be followed for intermediate outcomes.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in NYHA functional class 大体时间：Baseline and at 6 to 12 months	Change in New York Heart Association (NYHA) functional class from baseline to follow-up.	Baseline and at 6 to 12 months

次要结果测量

结果测量	措施说明	大体时间
Change in KCCQ-12 score 大体时间：From baseline to 6 to 12 months	Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) total score from baseline to follow-up (range 0-100, higher scores indicate better health status).	From baseline to 6 to 12 months
Change in left ventricular ejection fraction 大体时间：From baseline to 6 to 12 months	Change in left ventricular ejection fraction (LVEF) measured by echocardiography from baseline to follow-up.	From baseline to 6 to 12 months
Change in estimated glomerular filtration rate 大体时间：From baseline to 6 to 12 months	Change in estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation from baseline to follow-up.	From baseline to 6 to 12 months
Rate of heart failure hospitalization 大体时间：From baseline to 6 to 12 months	Number of heart failure-related hospital admissions during the follow-up period.	From baseline to 6 to 12 months
Proportion of patients on each GDMT component 大体时间：At 6 to 12 months	Proportion of patients prescribed each of the four foundational GDMT drug classes at follow-up.	At 6 to 12 months
Medication adherence score 大体时间：At 6 to 12 months	Mean Morisky Medication Adherence Scale-8 (MMAS-8) score (range 0-8, higher scores indicate better adherence).	At 6 to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assiut University

调查人员

学习椅：Ayman k Mohammed, prof、Cardiovascular Medicine Department, Assiut University Hospitals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月26日

初级完成 (估计的)

2027年9月26日

研究完成 (估计的)

2028年2月20日

研究注册日期

首次提交

2026年9月22日

首先提交符合 QC 标准的

2026年9月22日

首次发布 (实际的)

2026年9月28日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新