Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07821801

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure, Systolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in left ventricular ejection fraction

    Time frame: From baseline to 3 months

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

Secondary outcomes

  1. Change in KCCQ-12 score

    Time frame: 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.

  2. Change in eGFR

    Time frame: 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.

  3. Hospitalization for worsening heart failure

    Time frame: Up to 3 months

    Proportion of patients requiring hospitalization for worsening heart failure.

  4. Cardiovascular mortality

    Time frame: Up to 3 months

    Proportion of patients who die from cardiovascular causes.

  5. Worsening renal function

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

omar N Sayed, Resident

CONTACT

[email protected]

+20 10 64544293

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.