Heart FailureNCT07821801
Short-Term Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy
An observational study of Heart Failure and Heart Failure, Systolic, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure, Systolic
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 20 Mar 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with chronic heart failure with reduced ejection fraction (LVEF ≤40%) attending the Cardiovascular Department of Assiut University Hospitals.
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Heart Failure, Systolic
- Keywords
- therapy, LVEF, Guideline-directed medical, KCCQ-12, HFrEF, GDMT, Assiut
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular ejection fraction
Change in left ventricular ejection fraction (LVEF) percentage measured by transthoracic echocardiography from baseline to 3 months.
Measured: From baseline to 3 months
Secondary outcomes (5)
Change in KCCQ-12 score
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.
Measured: From baseline to 3 months
Change in eGFR
Change in estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) calculated by CKD-EPI equation from baseline to 3 months.
Measured: From baseline to 3 months
Hospitalization for worsening heart failure
Proportion of patients requiring hospitalization for worsening heart failure.
Measured: Up to 3 months
Cardiovascular mortality
Proportion of patients who die from cardiovascular causes.
Measured: Up to 3 months
Worsening renal function
Proportion of patients with worsening renal function defined as an increase in serum creatinine ≥0.3 mg/dL or ≥25% from baseline.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Nasr Sayed Ahmed, Assiut University
- Investigators
- Ayman k Mohammed, prof, Study chair, Cardiovascular medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821801
- Sponsor's protocol ID
- HFrEF-GDMT-Outcomes-Assiut-202
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34447992Bowers 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.
PubMed 25176168Packer 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.
PubMed 32865377
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Outcomes of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) in View of Current Guideline-Directed Medical Therapy
- ClinicalTrials.gov ID
- NCT07821801
- Acronym / sponsor ID
- HFrEF-GDMT-Outcomes-Assiut-202
- Conditions
- Heart Failure, Heart Failure, Systolic
- Keywords
- therapy, LVEF, Guideline-directed medical, KCCQ-12, HFrEF, GDMT, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic heart failure with reduced ejection fraction (LVEF ≤40%) attending the Cardiovascular Department of Assiut University Hospitals.
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Change in KCCQ-12 score
Time frame: From baseline to 3 months
Change in eGFR
Time frame: From baseline to 3 months
Hospitalization for worsening heart failure
Time frame: Up to 3 months
Cardiovascular mortality
Time frame: Up to 3 months
Worsening renal function
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 34447992McDonagh 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.
- Background: PubMed 25176168Bowers 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.
- Background: PubMed 32865377Packer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayman k Mohammed, prof study chair
Cardiovascular medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure, Systolic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact omar N Sayed, Resident (+20 10 64544293, Omar.18323493@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular ejection fraction (time frame: From baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07821801, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.