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Not yet recruitingNCT07821801Updated Sep 17, 2026

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

An observational study in Heart Failure and Heart Failure, Systolic, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Primary conditionHeart Failure, SystolicRegistry: Heart FailureReclassifiedWhy we changed it
Registry
Heart Failure — the first condition term the registry derived for this study.
ClinicalTrials.gg
Heart Failure, Systolic
Why
  1. The study's listed conditions name Heart Failure, Systolic, a narrower term within Heart Failure.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

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

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Conditions studied

  • Heart Failure
  • Heart Failure, Systolic

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Keywords

  • therapy
  • LVEF
  • Guideline-directed medical
  • KCCQ-12
  • HFrEF
  • GDMT
  • Assiut
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In context

Heart Failure, Systolic Reclassified

230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.

This study's planned enrollment of 250 is close to the median of 250 across 54 observational studies indexed under Heart Failure, Systolic.

Browse Heart Failure, Systolic studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Heart Failure, Systolic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Failure. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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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 (LVEF ≤40%) attending the Cardiovascular Department of Assiut University Hospitals.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Age 18 years or older
  • Diagnosis of chronic HFrEF ( ≤40%) documented by echocardiography
  • Stable on or planned initiation of guideline-directed medical therapy
  • Ability to provide

Exclusion criteria

Exclusion Criteria:

  • - Acute decompensated heart failure requiring intravenous inotropes at enrollment
  • End-stage renal disease on dialysis
  • \<20 mL/min/1.73 m² at baseline
  • Severe primary valvular disease requiring intervention
  • less than 3 months due to non-cardiac illness
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Change in left ventricular ejection fraction

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

    Time frame: From baseline to 3 months

Secondary outcomes

  1. 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.

    Time frame: From baseline to 3 months

  2. 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.

    Time frame: From baseline to 3 months

  3. Hospitalization for worsening heart failure

    Proportion of patients requiring hospitalization for worsening heart failure.

    Time frame: Up to 3 months

  4. Cardiovascular mortality

    Proportion of patients who die from cardiovascular causes.

    Time frame: Up to 3 months

  5. 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.

    Time frame: Up to 3 months

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Study locations

No study locations are listed for this record.

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References and documents

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 34447992 ↗
  • 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. PubMed 25176168 ↗
  • 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. PubMed 32865377 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 27 observational studies under Heart Failure, Systolic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 53. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 16, 2026
StartEst.
Sep 10, 2026
Primary completionEst.
Sep 10, 2027
CompletionEst.
Mar 20, 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07821801
Lead sponsor
Assiut University
Responsible party
Omar Nasr Sayed Ahmed (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 16, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Sep 10, 2027 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

omar N Sayed, Resident
Contact
Omar.18323493@med.aun.edu.eg
+20 10 64544293
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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Discussion

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