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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Karim A Ali, Resident
- Telefonnummer: +20 10 69625533
- E-post: kbs621304@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adult patients with chronic heart failure with reduced ejection fraction attending the Cardiovascular Department at Assiut University.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in NYHA functional class
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in KCCQ-12 score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Ayman k Mohammed, prof, Cardiovascular Medicine Department, Assiut University Hospitals
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HFrEF-GDMT-Assiut-2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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