Heart Failure With Reduced Ejection FractionNCT07845201
Intermediate Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy
An observational study of Heart Failure With Reduced Ejection Fraction and HFrEF - Heart Failure With Reduced Ejection Fraction, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, HFrEF - Heart Failure With Reduced Ejection Fraction
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 20 Feb 2028
- 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 attending the Cardiovascular Department at Assiut University.
Who may be able to join
- 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
Who cannot join
- - 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
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: Intermediate Outcomes of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) in View of Current Guideline-Directed Medical Therapy
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.
- Conditions
- Heart Failure With Reduced Ejection Fraction, HFrEF - Heart Failure With Reduced Ejection Fraction
- Keywords
- Guideline-directed medical therapy, GDMT, HFrEF, Assiut, Heart failure outcomes
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: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NYHA functional class
Change in New York Heart Association (NYHA) functional class from baseline to follow-up.
Measured: Baseline and at 6 to 12 months
Secondary outcomes (6)
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).
Measured: From baseline to 6 to 12 months
Change in left ventricular ejection fraction
Change in left ventricular ejection fraction (LVEF) measured by echocardiography from baseline to follow-up.
Measured: From baseline to 6 to 12 months
Change in estimated glomerular filtration rate
Change in estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation from baseline to follow-up.
Measured: From baseline to 6 to 12 months
Rate of heart failure hospitalization
Number of heart failure-related hospital admissions during the follow-up period.
Measured: From baseline to 6 to 12 months
Proportion of patients on each GDMT component
Proportion of patients prescribed each of the four foundational GDMT drug classes at follow-up.
Measured: At 6 to 12 months
Medication adherence score
Mean Morisky Medication Adherence Scale-8 (MMAS-8) score (range 0-8, higher scores indicate better adherence).
Measured: At 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion20 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Atef Ali Ahmed, Assiut University
- Investigators
- Ayman k Mohammed, prof, Study chair, Cardiovascular Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845201
- Sponsor's protocol ID
- HFrEF-GDMT-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate Outcomes of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) in View of Current Guideline-Directed Medical Therapy
- ClinicalTrials.gov ID
- NCT07845201
- Acronym / sponsor ID
- HFrEF-GDMT-Assiut-2026
- Conditions
- Heart Failure With Reduced Ejection Fraction, HFrEF - Heart Failure With Reduced Ejection Fraction
- Keywords
- Guideline-directed medical therapy, GDMT, HFrEF, Assiut, Heart failure outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 28 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
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 attending the Cardiovascular Department at Assiut University.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- - 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
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 NYHA functional class
Time frame: Baseline and at 6 to 12 months
Change in New York Heart Association (NYHA) functional class from baseline to follow-up.
6 secondary outcomes
Change in KCCQ-12 score
Time frame: From baseline to 6 to 12 months
Change in left ventricular ejection fraction
Time frame: From baseline to 6 to 12 months
Change in estimated glomerular filtration rate
Time frame: From baseline to 6 to 12 months
Rate of heart failure hospitalization
Time frame: From baseline to 6 to 12 months
Proportion of patients on each GDMT component
Time frame: At 6 to 12 months
Medication adherence score
Time frame: At 6 to 12 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 30 Sep 2026.
- Individual participant dataSharing planned: No
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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 With Reduced Ejection Fraction and HFrEF - Heart Failure With Reduced Ejection Fraction, 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 30 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 Karim A Ali, Resident (+20 10 69625533, kbs621304@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NYHA functional class (time frame: Baseline and at 6 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.