An observational study in Heart Failure, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Assiut University · Observational
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.
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:
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 .
A direct head-to-head comparison of MAGGIC, GWTG-HF, and SHFM in Egyptian patients has never been conducted. Such validation will provide clinicians with evidence on which model is most accurate for predicting 1-year mortality and 30-day readmission, and whether recalibration is needed to optimize performance for local practice.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 140 is below the median of 200 across 1,678 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Egyptian patients with heart failure
Age ≥18 years.
Cardiogenic shock requiring immediate MCS at presentation (analyzed separately).
Validation and Recalibration
* 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).
Time frame: 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Assiut University