Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction

• Status: Completed
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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 followed for 12 weeks for the assessment of safety and tolerability. Safety measures included incidence of hypotension, renal dysfunction, hyperkalemia, and angioedema

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Cardiovascular Diseases, Karachi
• Treatments: Angiotensin Receptor Antagonists; Valsartan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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