Interventional Active not recruiting Phase 4
NCT04103554 on ClinicalTrials.gov
Sacubitril/Valsartan in Left Ventricular Assist Device Recipients
Official title: A Multicenter, Randomized, Open-label, Parallel Group, Pilot Study to Evaluate the Use of Sacubitril/Valsartan in HeartMate 3 LVAD Recipients
- Sponsor: University of Zagreb
- Enrollment: 60 (Actual)
- Study start: 2021-02-05 (Actual)
- Primary completion: 2025-02-01 (Estimated)
- Study completion: 2025-02-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Single (Outcomes Assessor)
- PrimaryPurpose: Treatment
Brief 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
- Heart Failure
Intervention / Treatment
- Drug: Sacubitril-Valsartan
- Drug: Standard of care
Primary Outcome Measures
-
Freedom from all-cause death, deterioration in renal function (reaching end-stage renal disease (ESRD), renal death or 50% decline in eGFR), hyperkalemia or symptomatic hypotension
(3 months)
* End-stage renal disease defined as one of the following: 1. Initiation of dialysis (e.g., hemodialysis, peritoneal dialysis, or continuous venovenous hemodialysis), continuing for ≥ 20 days without known recovery of renal function 2. Initiation of dialysis with death before 30 days (excludes dialysis events associated with acute kidney injury with death before 30 days) 3. A drop in eGFR from baseline (randomization, i.e. Visit 101) to a value \<15 mL/min/1.73m2 on two consecutive measurements separated by≥ 20 days 4. Occurrence of kidney transplantation * 50% sustained decline in eGFR: 50% decline from baseline (Randomization, Visit 101) as determined by 2 consecutive post-baseline measurements separated by ≥ 20 days * Hyperkalemia: serum potassium ≥6.0 mmol/L \[mEq/L\]) Hypotension: symptomatic reduction in blood pressure requiring withdrawal of study medication or any BP lowering medication
Countries
Croatia, Czechia, Netherlands, Poland
Locations and Investigators
- University Hospital Centre Zagreb, Zagreb, Croatia
- University Hospital Dubrava, Zagreb, Croatia
- IKEM, Praha, Czechia
- Erasmus Medical Centre, Rotterdam, Netherlands
- University Medical Centre Utrecht, Utrecht, Netherlands
- John Paul II Hospital, Kraków, Poland
Study Officials
- Maja Cikes, MD, PhD (Principal Investigator) — University of Zagreb School of Medicine