Trials / Unknown
UnknownNCT04103554
Sacubitril/Valsartan in Left Ventricular Assist Device Recipients
A Multicenter, Randomized, Open-label, Parallel Group, Pilot Study to Evaluate the Use of Sacubitril/Valsartan in HeartMate 3 LVAD Recipients
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- University of Zagreb · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-02-05
- Primary completion
- 2025-02-01
- Completion
- 2025-02-01
- First posted
- 2019-09-25
- Last updated
- 2024-03-27
Locations
6 sites across 4 countries: Croatia, Czechia, Netherlands, Poland
Source: ClinicalTrials.gov record NCT04103554. Inclusion in this directory is not an endorsement.