NCT07821801

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

September 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2028

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 10, 2026

Last Update Submit

September 15, 2026

Conditions

Heart FailureHeart Failure, Systolic

Keywords

therapyLVEFGuideline-directed medicalKCCQ-12HFrEFGDMTAssiut

Outcome Measures

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.

    From baseline to 3 months

Secondary Outcomes (5)

  • Change in KCCQ-12 score

    From baseline to 3 months

  • Change in eGFR

    From baseline to 3 months

  • Hospitalization for worsening heart failure

    Up to 3 months

  • Cardiovascular mortality

    Up to 3 months

  • Worsening renal function

    Up to 3 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with chronic heart failure with reduced ejection fraction (LVEF ≤40%) attending the Cardiovascular Department of Assiut University Hospitals.

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 34447992BACKGROUND

  • 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.

    PMID: 25176168BACKGROUND

  • 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.

    PMID: 32865377BACKGROUND

MeSH Terms

Conditions

Heart FailureHeart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ayman k Mohammed, prof

    Cardiovascular medicine Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

omar N Sayed, Resident

CONTACT

+20 10 64544293Omar.18323493@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 16, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

March 20, 2028

Last Updated

September 17, 2026

Record last verified: 2026-09