TOPLINE:
In recipients of a left ventricular assist device (LVAD), the use of the angiotensin-neprilysin inhibitor sacubitril/valsartan was feasible, safe, and well tolerated, yielding improved quality of life and reducing the need for blood pressure-lowering medications over 12 months.
METHODOLOGY:
- Controlling blood pressure is critical for maintaining optimal function of LVAD. The role of heart failure-specific therapies for managing blood pressure in recipients of an LVAD remains unclear.
- Researchers reported primary findings from a prospective open-label trial conducted at six European sites to evaluate the safety and tolerability of sacubitril/valsartan in recipients of the HeartMate 3 LVAD.
- They included 60 stable adult recipients of an LVAD (mean age, 57 years; 17% women) who were either newly implanted and ready for discharge or were ambulatory with an implant within the past year; all had a mean arterial pressure of > 75 mm Hg.
- Patients were randomly assigned to receive sacubitril/valsartan or standard of care (n = 30 per arm), with a target mean arterial pressure from 75 mm Hg to 90 mm Hg.
- The primary composite endpoint was time to death, deterioration of renal function, hyperkalemia, or symptomatic hypotension, assessed over 12 months. Several other parameters were assessed along with quality of life, measured using the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score.
TAKEAWAY:
- Over 12 months, the primary composite endpoint occurred in two patients on sacubitril/valsartan and five on standard of care, with no significant difference in risk (hazard ratio, 0.42; P = .30).
- Compared with those on standard of care, fewer patients on sacubitril/valsartan died (2 vs 1) or had deterioration of renal function (2 vs 0), although these differences were not statistically significant.
- At 12 months, patients on sacubitril/valsartan required nearly 1.09 fewer blood pressure-lowering medications than those on standard of care (P < .0001) and had a 10.6-point greater improvement in the KCCQ-OS score (P = .011).
- Most patients started sacubitril/valsartan at 24/26 mg twice daily, many were uptitrated, and the drug was interrupted in only two. No hyperkalemia occurred in either group.
IN PRACTICE:
“Sacubitril/valsartan was feasible, safe, and well tolerated, with directional trends in clinical parameters favoring it over SOC [standard of care]. Notably, it improved patient-reported outcomes and reduced the need for additional antihypertensive drugs, offering meaningful patient-centered benefits. These findings lay the groundwork for larger trials of HF [heart failure] therapies in LVAD-supported patients,” the researchers reported.
SOURCE:
This study was led by Maja Cikes, MD, PhD, of University Hospital Centre Zagreb in Zagreb, Croatia. It was published online on August 31, 2025, in JACC: Heart Failure.
LIMITATIONS:
This study had a small sample size and an open-label design. Standard of care was used for comparisons instead of a double-blind placebo. Representation of women and individuals from diverse racial backgrounds was limited.
DISCLOSURES:
This trial was supported by institutional grants from Novartis and Abbott’s Heart Failure Division. Cikes reported receiving research and travel grants, clinical study contracts, and speaker honoraria from and serving in advisory roles at various pharmaceutical and healthcare companies including Novartis, Abbott, and Pfizer. Several other authors reported having similar financial ties with multiple organizations.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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