REBALANCE-HFrEF
Research type
Research Study
Full title
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure with Reduced Ejection Fraction: Randomized Controlled Feasibility Trial - The REBALANCE-HFrEF Study
IRAS ID
368415
Contact name
Judit Adorján
Contact email
Sponsor organisation
Axon Therapies
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
Heart failure with reduced ejection fraction (HFrEF) is a long-term condition in which the heart cannot pump blood effectively. This can lead to shortness of breath, tiredness, fluid retention, and repeated hospitalisations. Even with modern medicines, many patients continue to have symptoms and experience worsening heart failure.
The REBALANCE-HFrEF Study is clinical research evaluating a new minimally invasive procedure designed to reduce activity of a nerve called the right greater splanchnic nerve (GSN). This nerve helps regulate blood distribution throughout the body. In people with HFrEF, the GSN may be overactive, causing too much blood to shift toward the heart and lungs. This can increase pressure and worsen symptoms. Treating this nerve may help move blood back into the abdominal circulation, reduce pressure on the heart, and improve symptoms.
The procedure uses an investigational device called the Satera Ablation System, which delivers controlled radiofrequency energy through a thin tube (catheter) placed into a vein. The device gently interrupts nerve signals. This approach is called Splanchnic Ablation for Volume Management (SAVM). If a participant is assigned to the sham group, all steps of the procedure are simulated, but no ablation energy is delivered, and the nerve is not treated.
Up to 50 adults aged 40 years or older with HFrEF will participate across up to 15 hospitals worldwide. Participants will be randomly assigned in a 2:1 ratio to receive either the active or a sham procedure. Neither the participant nor their heart‑failure doctor will know which group the participant is assigned to.
The main goal of the study is to assess safety. The study will also look for early signs of benefit, including changes in symptoms, quality of life, exercise capacity, hospitalisations and a blood marker of heart failure severity (NT-proBNP). Participants will be followed for up to 12 months.
REC name
London - Stanmore Research Ethics Committee
REC reference
26/LO/0312
Date of REC Opinion
1 Jun 2026
REC opinion
Further Information Favourable Opinion