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Not yet recruitingNCT07845201Updated Sep 30, 2026

Intermediate Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy

An observational study in Heart Failure With Reduced Ejection Fraction and HFrEF - Heart Failure With Reduced Ejection Fraction, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction
  • HFrEF - Heart Failure With Reduced Ejection Fraction

Keywords

  • Guideline-directed medical therapy
  • GDMT
  • HFrEF
  • Assiut
  • Heart failure outcomes
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Change in NYHA functional class

    Change in New York Heart Association (NYHA) functional class from baseline to follow-up.

    Time frame: Baseline and at 6 to 12 months

Secondary outcomes

  1. Change in KCCQ-12 score

    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).

    Time frame: From baseline to 6 to 12 months

  2. Change in left ventricular ejection fraction

    Change in left ventricular ejection fraction (LVEF) measured by echocardiography from baseline to follow-up.

    Time frame: From baseline to 6 to 12 months

  3. Change in estimated glomerular filtration rate

    Change in estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation from baseline to follow-up.

    Time frame: From baseline to 6 to 12 months

  4. Rate of heart failure hospitalization

    Number of heart failure-related hospital admissions during the follow-up period.

    Time frame: From baseline to 6 to 12 months

  5. Proportion of patients on each GDMT component

    Proportion of patients prescribed each of the four foundational GDMT drug classes at follow-up.

    Time frame: At 6 to 12 months

  6. Medication adherence score

    Mean Morisky Medication Adherence Scale-8 (MMAS-8) score (range 0-8, higher scores indicate better adherence).

    Time frame: At 6 to 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07845201
Lead sponsor
Assiut University
Responsible party
Karim Atef Ali Ahmed (Resident Physician, Department of Cardiovascular medicine, Assiut University) — Principal investigator
First posted
Sep 28, 2026
Start date
Sep 26, 2026 (estimated)
Primary completion
Sep 26, 2027 (estimated)
Completion
Feb 20, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Karim A Ali, Resident
Contact
kbs621304@gmail.com
+20 10 69625533
Ayman k Mohammed, prof
study chair · Cardiovascular Medicine Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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