Splanchnic Nerve Block for Heart Failure
(Splanchnic X Trial)
Trial Summary
What is the purpose of this trial?
Heart failure (HF) affects more than 6 million adults in the U.S. alone, with increasing prevalence. Cardiovascular congestion with resultant limitation in physical activity is the hallmark of chronic and decompensated HF. The current HF physiologic model suggests that congestion is the result of volume retention and, therefore, therapies (such as diuretics) have generally been targeted at volume overload. Yet therapeutic approaches to reduce congestion have failed to show significant benefit on clinical outcomes, potentially due to an untargeted approach of decongestive therapies. The investigators' preliminary work suggested a complimentary contribution of volume redistribution to the mechanism of cardiac decompensation. The investigators identified the splanchnic nerves as a potential therapeutic target and showed that short-term interruption of the splanchnic nerve signaling could have favorable effects on cardiovascular hemodynamics and symptoms. As part of the investigators' proposal, the investigators will test the safety and efficacy of prolonged splanchnic nerve block in a randomized, controlled, blinded study in patients with HF and reduced ejection fraction (HFrEF). The results will help test the hypothesis of volume redistribution as a driver of cardiovascular congestion and functional limitations and pave the way for splanchnic nerve blockade as a novel therapeutic approach to HF.
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 data supports the effectiveness of the treatment Splanchnic Nerve Block for heart failure?
Research suggests that blocking the splanchnic nerve can help reduce the pressure in the heart and improve exercise capacity in some heart failure patients. This treatment has shown promising results in early studies, although more research is needed to fully understand its long-term safety and effectiveness.12345
Is the splanchnic nerve block generally safe for humans?
Splanchnic nerve block has been used in clinical practice for chronic abdominal pain and is generally well tolerated, with side effects like temporary diarrhea, stomach cramps, and low blood pressure. However, the long-term safety of this treatment specifically for heart failure is still unknown and needs more research.12346
How is the splanchnic nerve block treatment different from other heart failure treatments?
Splanchnic nerve block is a novel treatment for heart failure that targets the greater splanchnic nerve to reduce excessive fluid buildup and improve exercise capacity, unlike traditional treatments that may not address these specific issues. This approach is unique because it modulates nerve activity to manage heart failure symptoms, which is different from standard drug therapies.12346
Research Team
Manesh Patel, MD
Principal Investigator
Duke University
Eligibility Criteria
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
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
Treatment Details
Interventions
- Splanchnic Nerve Block
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor