Status:
COMPLETED
Sodium-glucose Transport 2 Inhibitors (SGLT2i) in HFrEF Patients
Lead Sponsor:
Damanhour University
Conditions:
Heart Failure
Reduced Ejection Fraction Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim of this study is to assess the efficacy, safety and cardiovascular outcomes of Sodium-glucose transport protein 2 inhibitors (SGLT2i) therapy in patients with heart failure reduced ejection fr...
Detailed Description
* A 3 months, prospective interventional study, which will include 80 patients with established heart failure reduced ejection fraction on optimal standard medical therapy, who will be consecutively r...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with HFrEF, on optimal medical therapy according to European Society of Cardiology guidelines,
- an age of at least 18 years,
- an ejection fraction of 40% or less, with New York Heart Association (NYHA) class II - IV symptoms will be eligible for the study.
- Exclusion criteria:
- Recent treatment with or unacceptable side effects associated with an SGLT2i
- Type-I diabetes mellitus,
- Symptoms of hypotension or a systolic blood pressure of less than 95 mm Hg,
- Severe CKD and an estimated glomerular filtration rate (eGFR) below 30 ml per minute per 1.73 m2 of body-surface area or rapidly declining renal function
- Inability to give informed consent
Exclusion
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06065280
Start Date
November 1 2022
End Date
December 30 2024
Last Update
February 4 2025
Active Locations (1)
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1
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
Damanhūr, Elbehairah, Egypt, 31527