Short-Term Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy

N/ANot Yet RecruitingNCT07821801

Assiut University250 enrolled

Overview

This prospective cohort study aims to evaluate short-term (3-month) clinical, renal, and functional outcomes in patients with heart failure with reduced ejection fraction treated with contemporary guideline-directed medical therapy at Assiut University Hospitals.

Heart failure with reduced ejection fraction (HFrEF) remains a major cause of morbidity and mortality. Guideline-directed medical therapy (GDMT) with the four foundational drug classes has improved outcomes in clinical trials, but real-world short-term data from low- and middle-income settings are limited. This observational study will include adult patients with chronic HFrEF (LVEF ≤40%) who are stable on or planned for initiation of guideline-directed medical therapy. Patients will be followed for 3 months with assessment of left ventricular ejection fraction, quality of life (KCCQ-12), renal function, and clinical events.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Heart Failure Heart Failure, Systolic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \- Age 18 years or older * Diagnosis of chronic HFrEF (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 \<20 mL/min/1.73 m² at baseline * Severe primary valvular disease requiring intervention * Life expectancy less than 3 months due to non-cardiac illness

Outcomes

Primary Outcomes

Change in left ventricular ejection fraction

Change in left ventricular ejection fraction (LVEF) percentage measured by transthoracic echocardiography from baseline to 3 months.

Time frame: From baseline to 3 months

Secondary Outcomes

Change in KCCQ-12 score

Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) total score from baseline to 3 months. The KCCQ-12 score ranges from 0 to 100; higher scores indicate better health status and quality of life.

Time frame: From baseline to 3 months

Change in eGFR

Change in estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) calculated by CKD-EPI equation from baseline to 3 months.

Time frame: From baseline to 3 months

Hospitalization for worsening heart failure

Proportion of patients requiring hospitalization for worsening heart failure.

Time frame: Up to 3 months

Cardiovascular mortality

Proportion of patients who die from cardiovascular causes.

Time frame: Up to 3 months

Worsening renal function

Proportion of patients with worsening renal function defined as an increase in serum creatinine ≥0.3 mg/dL or ≥25% from baseline.

Time frame: Up to 3 months

Central Contacts

omar N Sayed, Resident

CONTACT

+20 10 64544293 Omar.18323493@med.aun.edu.eg

Data from ClinicalTrials.gov

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