Short-Term Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy
September 10, 2026 updated by: Omar Nasr Sayed Ahmed, Assiut University
Short-Term Outcomes of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) in View of Current 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.
Study Overview
Status
Not yet recruiting
Conditions
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.
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: omar N Sayed, Resident
- Phone Number: +20 10 64544293
- Email: Omar.18323493@med.aun.edu.eg
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients with chronic heart failure with reduced ejection fraction (LVEF ≤40%) attending the Cardiovascular Department of Assiut University Hospitals.
Description
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
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Single cohort: Patients with HFrEF on GDMT
Adult patients with chronic heart failure with reduced ejection fraction who are receiving or planned to receive guideline-directed medical therapy and will be followed for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From baseline to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From baseline to 3 months
|
|
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.
|
From baseline to 3 months
|
|
Hospitalization for worsening heart failure
Time Frame: Up to 3 months
|
Proportion of patients requiring hospitalization for worsening heart failure.
|
Up to 3 months
|
|
Cardiovascular mortality
Time Frame: Up to 3 months
|
Proportion of patients who die from cardiovascular causes.
|
Up to 3 months
|
|
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.
|
Up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ayman k Mohammed, prof, Cardiovascular medicine Department, Assiut University Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.
- McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Bowers ME, Ressler KJ. Interaction between the cholecystokinin and endogenous cannabinoid systems in cued fear expression and extinction retention. Neuropsychopharmacology. 2015 Feb;40(3):688-700. doi: 10.1038/npp.2014.225. Epub 2014 Sep 1.
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 10, 2026
Primary Completion (Estimated)
September 10, 2027
Study Completion (Estimated)
March 20, 2028
Study Registration Dates
First Submitted
September 10, 2026
First Submitted That Met QC Criteria
September 10, 2026
First Posted (Actual)
September 16, 2026
Study Record Updates
Last Update Posted (Actual)
September 16, 2026
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFrEF-GDMT-Outcomes-Assiut-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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