Clinical Trial to Test Implantable Device to Treat Diastolic Heart Failure

The HOPE4HF trial will evaluate a new type of electrical device designed to stimulate blood-flow sensors in patients with diastolic heart failure.

As reported in the Lakeland Ledger, a man in Florida who has been diagnosed with diastolic heart failure is the first US patient to receive the CVRx Rheos System, which is designed to stimulate “the blood-flow regulation sensors, known as baroreceptors, to get them communicating with the brain. It does that by sending signals that tell the sensors the blood pressure is high enough to require action from the brain.”

CVRx founder Robert Kieval told the Ledger that the Rheos System, which can be custom programmed for each patient in which it is implanted, “sends signals that the heart needs to rest,” which prompt the brain to “send signals to the body to relax the arteries and to slow the heart rate. That will give the heart more time to fill with blood, to reduce the fluid buildup and to decrease the load on the heart.”

According to the article, the Rheos device has been approved in Europe for treating patients with “severely high blood pressure.” Follow-up “will be completed in late 2010 on the United States clinical trial for using it with high blood pressure.” Click here to access an abstract from the European Society of Hypertension that summarizes three-year results from the Rheos DEBuT-HT study, in which “a cohort of patients who underwent chronic Rheos therapy were assessed to analyze if therapeutic responsiveness was sustained.”

HOPE4HF Trial Underway

The Health Outcomes Prospective Evaluation for Heart Failure (HOPE4HF) trial is enrolling patients to evaluate the safety and effectiveness of the Rheos System in people with heart failure. The trial will determine whether “activating the baroreflex with the Rheos Device is safe and effective for heart failure heart failure patients,” and determine whether the Rheos Device an whether the Rheos Device can reduce heart failure symptoms, improve heart function, help patients with diastolic heart failure live longer, improve those patients’’ quality of life, and reduce the number of hospitalizations due to heart failure.

Eligible patients will be randomized to one of two groups: two-thirds will receive the Rheos Device plus medical management; one-third will receive medical management alone. Phase 1 of the trial will enroll 100 patients at up to 15 sites. Phase 2 will enroll 440 patients at up to 70 sites. Study visits will occur “at 1, 2, 3, 6, 9, 12, 15, and 18 months post-randomization,” with “semi- annual visits after 18 months until study closure, with phone visits approximately three months after each semi-annual visit.”

Visit the HOPE4HF trial website for more information on eligibility requirements, a list of participating medical centers, and answers to frequently asked questions about the Rheos Device and heart failure.

Additional Resources

Click here to access an abstract from Circulation that summarizes results from a study that looked at the effect of “Baroreflex Activation Therapy” provided by the Rheos System on “on myocardial energetics and mechanical efficiency” in patients with resistant hypertension.

This video “describes the problems associated with heart failure. It also discusses the Rheos System; Baroreflex Activation Therapy; and the HOPE4HF Trial.”