Splanchnic Nerve Block for Heart Failure
(Splanchnic X Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assist individuals with heart failure, a condition where the heart does not pump blood effectively. Researchers are testing whether blocking signals in the splanchnic nerves, which affect blood flow and pressure, through a procedure called a splanchnic nerve block, can improve heart function and relieve symptoms. Participants will receive either the actual nerve treatment or a sham (fake) procedure to compare results. The trial seeks individuals with heart failure with reduced ejection fraction, who experience symptoms like shortness of breath or fatigue despite stable medication use. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new treatment options for heart failure.
Will I have to stop taking my current medications?
The trial requires that participants have a stable heart failure drug regimen for the preceding month, so you will need to continue your current medications.
What prior data suggests that this splanchnic nerve block is safe for heart failure patients?
Research has shown that splanchnic nerve block treatments have potential to improve heart function, particularly in heart failure patients with preserved ejection fraction. Studies suggest this treatment might help reduce heart congestion. Evidence from these studies indicates that the procedure is generally well-tolerated.
While some safety considerations exist, these studies have not highlighted specific side effects or adverse events. This suggests that, although the treatment is still under investigation, no major safety concerns have been consistently reported. However, discussing any concerns with a healthcare professional is important before considering participation in a trial.12345Why are researchers excited about this trial?
Most treatments for heart failure, like beta-blockers and ACE inhibitors, focus on managing symptoms and slowing disease progression. But splanchnic nerve block offers a different approach by directly targeting the nervous system to potentially reduce the stress on the heart. This technique involves a catheter-based ablation of the right greater splanchnic nerve, which may lead to improved heart function and relief from symptoms more quickly than traditional medications. Researchers are excited about its potential to provide a new avenue for heart failure management, especially for patients who may not respond well to standard treatments.
What evidence suggests that the splanchnic nerve block might be an effective treatment for heart failure?
This trial will compare the effects of a splanchnic nerve block with a sham control procedure for heart failure. Research has shown that a splanchnic nerve block might benefit people with heart failure. Previous studies found that blocking the greater splanchnic nerve can improve heart function. This treatment may reduce congestion in the heart, which occurs when excess blood builds up, causing the heart to work harder. Studies in individuals with a similar type of heart failure have demonstrated that this method can improve blood flow and reduce symptoms. This treatment could provide a new way to help those with heart failure feel better and be more active.12345
Who Is on the Research Team?
Manesh Patel, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with heart failure and reduced ejection fraction (HFrEF), where the heart's left ventricle pumps out less than half of the blood it receives. Participants must have a stable heart medication routine, increased heart rate during activity, specific symptoms and pressure levels in their hearts, and adequate kidney function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo splanchnic nerve block or sham procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Splanchnic Nerve Block
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor