Pulmonary Artery Denervation for Pulmonary Hypertension

(The PULSE-LHD Trial)

This trial tests a new treatment called the Enhancor System, a procedure known as Pulmonary Artery Denervation, for individuals with pulmonary hypertension linked to left heart disease. Researchers aim to determine if this treatment is safe and effective compared to standard medical therapy. The trial includes two groups: one will receive the new treatment along with standard care, while the other will receive standard care alone. It seeks patients who have remained stable with chronic heart failure and pulmonary hypertension, confirmed by special testing, despite being on optimal heart failure medication. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance future treatment options.

Research has shown that pulmonary artery denervation (PADN) is generally safe for individuals with pulmonary hypertension, which is high blood pressure in the lungs. Several studies have found that patients tolerate this treatment well. For example, one study found that patients who received PADN experienced fewer signs of their condition worsening compared to those who did not receive the treatment.

Researchers are excited about the Enhancor System for pulmonary hypertension because it offers a novel approach by targeting the nerves around the pulmonary artery, which is different from the usual medications that mostly focus on relaxing blood vessels or reducing blood volume. This method, known as pulmonary artery denervation (PADN), may help reduce pressure in the lungs more directly and effectively. Unlike current treatments, which often require a combination of drugs to manage symptoms, PADN could offer a more targeted and potentially longer-lasting solution.

This trial will compare Pulmonary Artery Denervation (PADN) with a control procedure for patients with pulmonary hypertension. Studies have shown that PADN can significantly benefit patients with this condition, characterized by high blood pressure in the lungs. Previous research demonstrated that PADN improved patients' exercise capacity and reduced symptoms, enabling them to walk longer distances. It also decreased resistance in the lung blood vessels, easing the heart's effort to pump blood and reducing average lung blood pressure. One study reported an average drop of 6.9 mmHg in lung blood pressure. These findings suggest that PADN might effectively treat the condition, particularly for those with persistent symptoms.¹²³⁴⁵