Intermediate 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- 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

Trial population

Adult patients with chronic heart failure with reduced ejection fraction attending the Cardiovascular Department at Assiut University.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 1 trial group
Group A: Single cohort: HFrEF patients on GDMT

Trial outcomes

Primary outcomes

1

Change in NYHA functional class

Change in New York Heart Association (NYHA) functional class from baseline to follow-up.

Time frame
Baseline and at 6 to 12 months

Secondary outcomes

1

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).

Time frame
From baseline to 6 to 12 months
2

Change in left ventricular ejection fraction

Change in left ventricular ejection fraction (LVEF) measured by echocardiography from baseline to follow-up.

Time frame
From baseline to 6 to 12 months
3

Change in estimated glomerular filtration rate

Change in estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation from baseline to follow-up.

Time frame
From baseline to 6 to 12 months
4

Rate of heart failure hospitalization

Number of heart failure-related hospital admissions during the follow-up period.

Time frame
From baseline to 6 to 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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