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Angiotensin-Neprilysin Inhibition and Left Ventricular Assist Device Therapy: Primary Results of the ENVAD-HF Trial

Maja Cikes1, Jasper J Brugts2, Brian Claggett3

  • 1Department of Cardiovascular Diseases, University of Zagreb School of Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.

JACC. Heart Failure
|September 2, 2025
PubMed

Insights

The ENVAD-HF trial found sacubitril/valsartan safe and tolerable for HeartMate 3 left ventricular assist device (LVAD) recipients. This heart failure therapy showed a trend toward improved outcomes, supporting further investigation in LVAD patients.

Area of Science:

  • Cardiology
  • Medical Devices
  • Pharmacology

Background:

  • The efficacy of heart failure therapies in left ventricular assist device (LVAD) recipients remains under investigation.
  • Observational studies suggest neurohormonal blockers may improve outcomes in LVAD patients.
  • The ENVAD-HF trial assessed the safety and tolerability of sacubitril/valsartan in HeartMate 3 LVAD recipients.

Purpose of the Study:

  • To evaluate the safety and tolerability of sacubitril/valsartan for blood pressure management in HeartMate 3 LVAD recipients.
  • To compare sacubitril/valsartan against standard of care (SOC) in this patient population.
  • To establish a basis for future pivotal trials on heart failure-specific therapies in LVAD recipients.

Main Methods:

  • A prospective, multicenter, randomized, open-label study (ENVAD-HF) was conducted.
  • Stable LVAD recipients were randomized to receive either sacubitril/valsartan or SOC for blood pressure management (MAP goal 75-90 mmHg).
  • The study included a 12-month follow-up with a composite primary endpoint and exploratory clinical, biomarker, and patient-reported outcome assessments.

Main Results:

  • The primary endpoint (time to death, renal function deterioration, hyperkalemia, or hypotension) showed a hazard ratio of 0.42 (p=0.30) favoring sacubitril/valsartan, though not statistically significant.
  • Fewer primary endpoint events occurred in the sacubitril/valsartan group (2 events) compared to the SOC group (5 events).
  • Sacubitril/valsartan use was associated with a significant reduction in blood pressure medications (p <0.0001) and improved Kansas City Cardiomyopathy Questionnaire Overall Summary Score (p=0.011).

Conclusions:

  • The ENVAD-HF trial demonstrated that sacubitril/valsartan is safe and well-tolerated in stable HeartMate 3 LVAD recipients.
  • This study provides evidence supporting the investigation of Angiotensin-Neprilysin Inhibition in the LVAD population.
  • The findings pave the way for a pivotal trial to confirm the clinical utility of HF-specific therapies in LVAD patients.
Abstract

Keywords:
advanced heart failureblood pressureleft ventricular assist deviceneurohormonal blocking therapyoutcomessacubitril/valsartan

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