跳至主要内容
临床试验/NCT07194889
NCT07194889尚未招募不适用

External Validation and Recalibration of Heart Failure Risk Models (MAGGIC, GWTG-HF, and SHFM) in Egyptian Patients

Assiut University0 个研究点目标入组 140 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
主要终点
Validation and Recalibration

研究概览

简要总结

Heart failure (HF) affects over 64 million people worldwide and carries high morbidity, frequent hospitalizations, and major economic burden. Accurate risk stratification is essential to guide therapy, follow-up, and advanced care decisions.

Several prognostic models have been developed:

MAGGIC: based on >39,000 patients, predicts mortality from simple clinical variables.

GWTG-HF: derived from >30,000 patients, predicts in-hospital mortality using admission data.

SHFM: estimates 1-3 year survival, incorporating clinical, lab, and treatment factors.

These models, developed mainly in Western cohorts, may not perform well in Arab populations, where HF patients are younger, with more ischemic disease, diabetes, CKD, and limited access to advanced therapies. Such differences risk score miscalibration.

External validation and recalibration are needed to assess predictive accuracy and adjust models for local populations. A head-to-head comparison of MAGGIC, GWTG-HF, and SHFM has never been done in Egypt; such a study would identify the most reliable model for predicting 1-year mortality and 30-day readmission in Egyptian HF patients.

详细描述

Heart failure (HF) is a major global public health problem, affecting more than 64 million people worldwide [1]. It is associated with high morbidity, frequent hospitalizations, poor quality of life, and substantial economic burden [2]. Accurate risk stratification is central to HF management: it helps guide treatment intensity, identify patients needing closer follow-up, and informs advanced therapy referral and patient counseling.

Over the last two decades, several prognostic models have been developed to predict outcomes in HF patients:

  1. Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC): derived from >39,000 patients in 30 cohort studies, predicting mortality based on simple clinical and demographic variables [3]. It has been externally validated in Western and Asian cohorts [4].
  2. Get With The Guidelines-Heart Failure (GWTG-HF) risk score: developed from the American Heart Association registry (>30,000 patients), primarily for in-hospital mortality, based on admission data such as SBP, HR, sodium, and BUN [5]. It has shown good predictive value in US and Japanese patients [6,7].
  3. Seattle Heart Failure Model (SHFM): a comprehensive model estimating 1-3 year survival in chronic HF patients, integrating demographics, laboratory data, medications, and device therapies [8,9]. It is widely used in advanced HF and transplant referral.

While these models are widely applied, they were derived predominantly from North American and European cohorts. Their performance in Arab populations is uncertain. HF patients in Egypt and the Arab world often present younger, with higher rates of ischemic cardiomyopathy, diabetes, and chronic kidney disease compared with Western cohorts [11-13]. Access to novel therapies (e.g., ARNI, SGLT2 inhibitors) and device-based therapies is lower. and healthcare system constraints may contribute to higher early readmission rates [14]. These differences may lead to miscalibration of existing scores, systematically over- or underestimating risk in this population.

External validation is therefore essential to test model discrimination (ability to distinguish high vs. low risk patients) and calibration (agreement between predicted and observed risk). When miscalibration is found, models can undergo recalibration (adjustment of intercept and/or slope) to improve local performance without discarding their predictive structure .

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Validation and Recalibration

时间窗: 1 year

* To externally validate the MAGGIC, GWTG-HF, and SHFM models for predicting all-cause mortality at 1 year in Egyptian HF patients. * To validate the same models for predicting 30-day all-cause readmission * In-hospital mortality (for GWTG-HF validation). * All-cause mortality at 30 days and 1 year (for MAGGIC \& SHFM).

次要结局

未报告次要终点

研究者

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

Antonious Gamal

Resident doctor

Assiut University

相似试验