Intermediate Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy

September 26, 2026 updated by: Karim Atef Ali Ahmed, Assiut University

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

This prospective observational study aims to evaluate intermediate clinical, renal, and functional outcomes in patients with heart failure with reduced ejection fraction treated with contemporary guideline-directed medical therapy over a 6 to 12 month follow-up period.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Guideline-directed medical therapy (GDMT) is the cornerstone of treatment for heart failure with reduced ejection fraction. This observational study will enroll adult patients with chronic HFrEF (LVEF ≤ 40%) who are stable on or planned to initiate GDMT.

Patients will be followed for 6 to 12 months to assess changes in renal function, functional status, quality of life, left ventricular ejection fraction, hospitalization rates, and medication adherence.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Karim A Ali, Resident
Phone Number: +20 10 69625533
Email: kbs621304@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with chronic heart failure with reduced ejection fraction attending the Cardiovascular Department at Assiut University.

Description

Inclusion Criteria:

Age 18 years or older
Diagnosis of chronic HFrEF with 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 less than 20 mL/min/1.73 m² at baseline
Severe primary valvular disease requiring immediate intervention
Life expectancy less than 6 months due to non-cardiac illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: PROSPECTIVE

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Single cohort: HFrEF patients on GDMT Adult patients with heart failure with reduced ejection fraction who are receiving or planned to receive contemporary guideline-directed medical therapy and will be followed for intermediate outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NYHA functional class Time Frame: Baseline and at 6 to 12 months	Change in New York Heart Association (NYHA) functional class from baseline to follow-up.	Baseline and at 6 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in KCCQ-12 score Time Frame: From baseline to 6 to 12 months	Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) total score from baseline to follow-up (range 0-100, higher scores indicate better health status).	From baseline to 6 to 12 months
Change in left ventricular ejection fraction Time Frame: From baseline to 6 to 12 months	Change in left ventricular ejection fraction (LVEF) measured by echocardiography from baseline to follow-up.	From baseline to 6 to 12 months
Change in estimated glomerular filtration rate Time Frame: From baseline to 6 to 12 months	Change in estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation from baseline to follow-up.	From baseline to 6 to 12 months
Rate of heart failure hospitalization Time Frame: From baseline to 6 to 12 months	Number of heart failure-related hospital admissions during the follow-up period.	From baseline to 6 to 12 months
Proportion of patients on each GDMT component Time Frame: At 6 to 12 months	Proportion of patients prescribed each of the four foundational GDMT drug classes at follow-up.	At 6 to 12 months
Medication adherence score Time Frame: At 6 to 12 months	Mean Morisky Medication Adherence Scale-8 (MMAS-8) score (range 0-8, higher scores indicate better adherence).	At 6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Chair: Ayman k Mohammed, prof, Cardiovascular Medicine Department, Assiut University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

February 20, 2028

Study Registration Dates

First Submitted

September 22, 2026

First Submitted That Met QC Criteria