Intermediate Outcomes of HFrEF Patients on Guideline-Directed Medical Therapy

NCT07845201 | Not Yet Recruiting

• 1 other identifier: HFrEF-GDMT-Assiut-2026
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Change in NYHA functional class

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

  Baseline and at 6 to 12 months

Secondary Outcomes (6)

• Change in KCCQ-12 score

  From baseline to 6 to 12 months

• Change in left ventricular ejection fraction

  From baseline to 6 to 12 months

• Change in estimated glomerular filtration rate

  From baseline to 6 to 12 months

• Rate of heart failure hospitalization

  From baseline to 6 to 12 months

• Proportion of patients on each GDMT component

  At 6 to 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• Ayman k Mohammed, prof

  Cardiovascular Medicine Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Karim A Ali, Resident

CONTACT

+20 10 69625533; kbs621304@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Cardiovascular medicine

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: September 26, 2026
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): February 20, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share