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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07821801

Enrollment

250

Registered

2026-09-16

Start date

2026-09-10

Completion date

2028-03-20

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Heart Failure, Systolic

Keywords

therapy, LVEF, Guideline-directed medical, KCCQ-12, HFrEF, GDMT, Assiut

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in KCCQ-12 score	From baseline to 3 months	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.
Change in eGFR	From baseline to 3 months	Change in estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) calculated by CKD-EPI equation from baseline to 3 months.
Hospitalization for worsening heart failure	Up to 3 months	Proportion of patients requiring hospitalization for worsening heart failure.
Cardiovascular mortality	Up to 3 months	Proportion of patients who die from cardiovascular causes.
Worsening renal function	Up to 3 months	Proportion of patients with worsening renal function defined as an increase in serum creatinine ≥0.3 mg/dL or ≥25% from baseline.

Contacts

CONTACTomar N Sayed, Resident

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

STUDY_CHAIRAyman k Mohammed, prof

Cardiovascular medicine Department, Assiut University Hospitals

Outcome results