Comparison of High Versus Low Positive End-Expiratory Pressure in Mechanically Ventilated Patients With Acute Heart Failure: Rationale and Design of the HELP-AHF Trial.

Background and objectives: Acute decompensated heart failure (ADHF) often necessitates invasive mechanical ventilation (MV) due to respiratory failure. Positive end-expiratory pressure (PEEP) is a critical component in MV management; however, the optimal PEEP level for patients with ADHF remains unclear. The High vErsus Low Positive end-expiratory pressure in mechanically ventilated patients with Acute Heart Failure (HELP-AHF) trial is a multicenter, open-label, randomized controlled study designed to compare the efficacy and safety of high versus low PEEP strategies in this population.

Methods: A total of 120 patients with ADHF requiring MV within 24 hours of initiation will be randomized 1:1 to a high PEEP group (target: 10 cmH₂O) or a low PEEP group (target: 3 cmH₂O).

Results: The primary outcome is ventilator-free days at day 28. Key secondary outcomes include in-hospital mortality, duration of intensive care unit and hospital stay, vasoactive-inotropic support, and rates of heart transplantation or left ventricular assist device implantation. Safety outcomes include hemodynamic instability requiring mechanical circulatory support, pulmonary complications, and weaning-related adverse events.

Conclusions: This HELP-AHF trial aims to provide valuable insights into optimal PEEP strategies in ADHF patients receiving invasive MV. Findings from this study have the potential to inform ventilatory management practices and improve outcomes in this high-risk population.

Trial registration: ClinicalTrials.gov Identifier: NCT04853563.