Greater Splanchnic Nerve Ablation for Diastolic Heart Failure

(Rebalance-HF Trial)

This trial evaluates a new procedure called Endovascular Ablation of the Right Greater Splanchnic Nerve, which targets a nerve to help individuals with a specific type of heart failure. The focus is on heart failure with preserved ejection fraction (HFpEF), where the heart pumps normally but remains stiff and doesn't fill properly. Researchers aim to determine if this treatment, using the Satera Ablation System, can improve symptoms and identify those who might benefit most. This trial suits individuals with chronic heart failure symptoms, such as difficulty breathing during mild activity, who have used diuretics for more than 30 days. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for heart failure patients.

The trial does not specify if you need to stop taking your current medications. However, it mentions that you should have stable heart failure management without significant changes for at least 30 days before screening and maintain it for 6 months. It's best to discuss your specific medications with the trial team.

Research has shown that endovascular ablation of the right greater splanchnic nerve is generally safe. In one study, 26 patients with heart failure with preserved ejection fraction (HFpEF) underwent this procedure and reported positive safety results. Another small study also found that patients tolerated the procedure well. An independent group regularly reviews safety data to ensure participants' safety. Overall, these findings suggest the procedure is safe, but individual experiences may vary.¹²³⁴⁵

Researchers are excited about endovascular ablation of the right greater splanchnic nerve because it represents a novel approach for treating heart failure with preserved ejection fraction (HFpEF). Unlike traditional treatments such as diuretics and beta-blockers, which primarily manage symptoms, this procedure targets the nervous system directly by using the Satera Ablation System to precisely interrupt nerve signals that can contribute to heart failure. This innovative technique could offer a more targeted and potentially more effective intervention for patients who have limited options with standard care.

This trial investigates a new procedure called endovascular ablation of the right greater splanchnic nerve to assist individuals with heart failure known as HFpEF. Participants in one arm of the trial will undergo this procedure, which aims to manage fluid levels by influencing nerve signals related to heart function. Early results suggest the procedure is safe and can be performed successfully. However, previous studies did not demonstrate a decrease in heart stress during exercise or improvements in symptoms after 12 months. Although the treatment appears safe, further research is necessary to confirm its effectiveness in improving heart failure symptoms.¹²³⁵⁶