Short-Term Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
- 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
Trial population
Adult patients with chronic heart failure with reduced ejection fraction (LVEF ≤40%) attending the Cardiovascular Department of Assiut University Hospitals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: Single cohort: Patients with HFrEF on GDMT
Trial outcomes
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 monthsSecondary 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 months2
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 months3
Hospitalization for worsening heart failure
Proportion of patients requiring hospitalization for worsening heart failure.
Time frame
Up to 3 months4
Cardiovascular mortality
Proportion of patients who die from cardiovascular causes.
Time frame
Up to 3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: