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

NCT05387967 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-05-24

No results posted yet for this study

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

Conditions

  • Heart Failure, Systolic

Interventions

DRUG

Sacubitril/valsartan

All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks.

Sponsors & Collaborators

  • National Institute of Cardiovascular Diseases, Pakistan

    lead OTHER

Principal Investigators

  • Muhammad Nauman Khan, FCPS · National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387967 on ClinicalTrials.gov