Intermediate Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy
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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Karim A Ali, Resident
- Telefonnummer: +20 10 69625533
- E-post: kbs621304@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adult patients with chronic heart failure with reduced ejection fraction attending the Cardiovascular Department at Assiut University.
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- - 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in NYHA functional class
Tidsram: Baseline and at 6 to 12 months
|
Change in New York Heart Association (NYHA) functional class from baseline to follow-up. |
Baseline and at 6 to 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in KCCQ-12 score
Tidsram: From baseline to 6 to 12 months
|
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). |
From baseline to 6 to 12 months
|
|
Change in left ventricular ejection fraction
Tidsram: From baseline to 6 to 12 months
|
Change in left ventricular ejection fraction (LVEF) measured by echocardiography from baseline to follow-up. |
From baseline to 6 to 12 months
|
|
Change in estimated glomerular filtration rate
Tidsram: From baseline to 6 to 12 months
|
Change in estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation from baseline to follow-up. |
From baseline to 6 to 12 months
|
|
Rate of heart failure hospitalization
Tidsram: From baseline to 6 to 12 months
|
Number of heart failure-related hospital admissions during the follow-up period. |
From baseline to 6 to 12 months
|
|
Proportion of patients on each GDMT component
Tidsram: At 6 to 12 months
|
Proportion of patients prescribed each of the four foundational GDMT drug classes at follow-up. |
At 6 to 12 months
|
|
Medication adherence score
Tidsram: At 6 to 12 months
|
Mean Morisky Medication Adherence Scale-8 (MMAS-8) score (range 0-8, higher scores indicate better adherence). |
At 6 to 12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Ayman k Mohammed, prof, Cardiovascular Medicine Department, Assiut University Hospitals
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HFrEF-GDMT-Assiut-2026
Plan för individuella deltagardata (IPD)
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