What question did this study set out to answer?

This research aims to evaluate the effectiveness of Synchronized Diaphragmatic Stimulation in patients with heart failure and reduced ejection fraction.

March 12, 2026Open Access

RECOVER-HF: A Sham-Controlled, Double-Blind Pivotal Trial of Synchronized Diaphragmatic Stimulation in HFrEF

Key Result

Synchronized Diaphragmatic Stimulation (SDS) significantly enhances cardiac function in heart failure patients without affecting respiration.

Key Points

This research aims to evaluate the effectiveness of Synchronized Diaphragmatic Stimulation in patients with heart failure and reduced ejection fraction.
Double-blind trial design
Use of a sham control group
Implantation of an SDS device
Cardiac function assessment at multiple intervals
Significant enhancement in cardiac function observed
Patients reported no perceptible alteration in respiration
SDS demonstrated efficacy across various heart failure phenotypes

Structured PICO

Does Synchronized Diaphragmatic Stimulation (SDS) improve outcomes in patients with HFrEF?

Population

Patients with heart failure with reduced ejection fraction (HFrEF)

Intervention

Synchronized Diaphragmatic Stimulation (SDS)

Comparator

Sham control

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Synchronized Diaphragmatic Stimulation (SDS) is a novel implantable device-based intervention designed to augment cardiac function by applying cardiac-synchronized electrical stimulation to the diaphragm without altering respiration or being perceptible to patients 1–4. The diaphragm is widely known for its central role in breathing, but it also strongly affects loading and unloading of the heart. With each breath the diaphragm acts as an ancillary cardiac pump 5. SDS harnesses the diaphragm as a natural left-ventricular assist for heart failure patients, leveraging a mechanism of action that is largely independent of cardiac anatomy, heart failure phenotypes, and patient comorbidities.

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