Status:
COMPLETED
Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction
Lead Sponsor:
National Institute of Cardiovascular Diseases, Pakistan
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This proof-of-concept, open-label non-randomized clinical trial was conducted at a tertiary care cardiac center in Karachi, Pakistan. Patients with HFrEF were prescribed Sacubitril/Valsartan and follo...
Detailed Description
A required number of consecutive patients meeting the inclusion criteria were recruited for this study. After written informed consent patient demographic and baseline clinical characteristics were ob...
Eligibility Criteria
Inclusion
- Either gender
- between 18 to 80 years of age
- Diagnosed with Heart failure with reduced ejection fraction (HFrEF)
- New York Heart Association (NYHA) class II-IV
- Left ventricular ejection fraction (LVEF) ≤ 40%
- Stable on any dose of beta-blockers, ACEI or ARB
Exclusion
- Refused to participate in the study
- Patients with hyperkalemia
- Patients with hypotension
- Patients with renal dysfunction
- History of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT05387967
Start Date
January 1 2021
End Date
September 30 2021
Last Update
May 24 2022
Active Locations (1)
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1
National Institute of Cardiovascular Diseases
Karachi, Sindh, Pakistan, 75510