Sacubitril/Valsartan in Left Ventricular Assist Device Recipients
- Conditions
- Heart failureHeart failure with reduced ejection fraction Advanced Heart failureTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-003888-22-HR
- Lead Sponsor
- niversity of Zagreb School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1. Written informed consent must be obtained before any assessment is performed.
2. =18 years of age, male or female
3. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this 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 HM3 LVAD. ;Secondary Objective: The secondary objectives of this study are to assess the change in NT-proBNP, reduction in burden of hemocompatibility, reduction of RV failure, reduction of unplanned hospitalizations, reduction in number of blood-pressure lowering medications, improvement of renal function in patients implanted with the HM3 LVAD, treated with sacubitril/valsartan, compared with standard of care for treating blood pressure in this population. ;Primary end point(s): Freedom from all-cause death, deterioration in renal function (defined as reaching end-stage renal disease (ESRD), renal death or 50% sustained decline in eGFR), hyperkalemia or symptomatic hypotension leading to drug withdrawal during the active treatment period;Timepoint(s) of evaluation of this end point: 3 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change in NT-proBNP from enrolment to 8 weeks <br>- Reduction in Burden of hemocompatibility (hemocompatibility score) <br>- Reduction of RV failure <br>- Reduction of unplanned hospitalizations <br>- Reduction in number of blood-pressure lowering medications <br>- Improvement of renal function ;Timepoint(s) of evaluation of this end point: 8 weeks, 3 months, 12 months