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Sacubitril/Valsartan in Left Ventricular Assist Device Recipients

NCT04103554 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-27

No results posted yet for this study

Summary

The primary objective of this prospective randomised study is to assess the safety and tolerability of sacubitril/valsartan compared with standard of care used for treating BP in patients that have been implanted with the Heart Mate 3 LVAD (events of special interest - all cause death, right ventricular failure, bleeding events, deterioration in renal function, hyperkalemia, symptomatic hypotension).

Conditions

Interventions

DRUG

Sacubitril-Valsartan

Sacubitril-Valsartan 24/26 mg BID, 49/51 mg BID, 97/103 mg BID

DRUG

Standard of care

standard of care used for treating BP

Sponsors & Collaborators

  • University of Zagreb

    lead OTHER

Principal Investigators

  • Maja Cikes, MD, PhD · University of Zagreb School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Croatia
  • Czechia
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT04103554 on ClinicalTrials.gov