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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Sacubitril-Valsartan 24/26 mg BID, 49/51 mg BID, 97/103 mg BID
standard of care used for treating BP
University Hospital Centre Zagreb
Zagreb, Croatia
University Hospital Dubrava
Zagreb, Croatia
IKEM
Prague, Czechia
Erasmus Medical Centre
Rotterdam, Netherlands
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
* 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
Time frame: 3 months
Change in NT-proBNP from enrolment to 8 weeks
Time frame: 8 weeks
Change in Burden of hemocompatibility (hemocompatibility score)
Time frame: 3 months, 12 months
Number of RV failure events
Time frame: 3 months, 12 months
Time to first unplanned hospitalisation
Time frame: 3 months, 12 months
Number of unplanned hospitalizations
Time frame: 3 months, 12 months
Change in blood-pressure lowering medications
Time frame: 3 months, 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Medical Centre Utrecht
Utrecht, Netherlands
John Paul II Hospital
Krakow, Poland
Change in eGFR values
Time frame: 3 months, 12 months