Status:
ACTIVE_NOT_RECRUITING
Sacubitril/Valsartan in Left Ventricular Assist Device Recipients
Lead Sponsor:
University of Zagreb
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 be...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed.
- ≥18 years of age, male or female
- Recently implanted HeartMate 3 LVAD recipients, in stable condition and deemed ready for discharge or chronic, stable, ambulatory HeartMate 3 LVAD carriers implanted within 1 year prior to enrolment
- 1\. Current acute decompensated HF (including right ventricular failure) requiring therapy with intravenous diuretics or vasodilators and/or inotropic drugs within the past 48 hours 2. History of hypersensitivity to sacubitril/valsartan or to drugs of similar chemical classes, patients with a known history of angioedema 3. Patients with mean blood pressure ≤75 mmHg (systolic blood pressure i.e. Doppler opening blood pressure ≤90 mmHg in those pulsatile and measured by Doppler method) or symptomatic hypotension 4. eGFR \< 30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at Visit 1 5. Patients with serum potassium \>5.4 mmol/L (mEq/L) at Visit 1 6. Hemodynamically unstable patients or those with ongoing MCS other than LVAD or those with planned biventricular support 7. Hemodynamically significant aortic insufficiency in the opinion of the investigator 8. Irreversible end-organ dysfunction 9. Previous sacubitril/valsartan use while on LVAD support 10. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within 30 days prior to enrolment 11. Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate \>110 bpm at enrolment 12. Any surgical or medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 13. Active infection with hemodynamic compromise 14. hemoglobin (Hgb) \<8 g/dl 15. body mass index (BMI) \> 45 kg/m2 16. Congenital heart disease 17. Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the 6 months after enrolment 18. Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x ULN, bilirubin \>1.5 mg/dl at Visit 1 19. Pregnant or nursing (lactating) women and women of child-bearing potential unless they are using highly effective methods of contraception
Exclusion
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04103554
Start Date
February 5 2021
End Date
February 1 2025
Last Update
March 27 2024
Active Locations (6)
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1
University Hospital Centre Zagreb
Zagreb, Croatia, 10000
2
University Hospital Dubrava
Zagreb, Croatia, 10000
3
IKEM
Prague, Czechia
4
Erasmus Medical Centre
Rotterdam, Netherlands, 3015 GD