Status:
COMPLETED
The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
Lead Sponsor:
Amir Safwat
Conditions:
Heart Failure
Eligibility:
All Genders
40-60 years
Phase:
PHASE4
Brief Summary
The aim of this study is to evaluate the bio-clinical effects of sacubitril/valsartan combination in treatment of patients with Congestive heart failure. Moreover, the investigators aim to evaluate si...
Eligibility Criteria
Inclusion
- Age 40 - 60 years
- Patients with chronic congestive heart failure class ( II-IV) symptoms according to New York Heart Association (NYHA) classification
- Left Ventricular Ejection Fraction of 40% or less.
- NT-proBNP level of at least ≥400 pg per milliliter
- ACE-inhibitor or ARB therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day.
Exclusion
- Patients with symptomatic hypotension.
- Pregnant and nursing women
- Systolic blood pressure \< 100 mmHg at screening or \< 95 mmHg at randomization
- Patients with glomerular filtration rate \<30 mL/min/1.73 m2
- Patients with history of angioedema
- Patients with unacceptable side effects with ACE-inhibitors or ARBs.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04688294
Start Date
January 1 2020
End Date
July 1 2021
Last Update
June 24 2022
Active Locations (1)
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1
Wadi El-Neel Hospital
Cairo, Egypt, 11865