RecruitingNot ApplicableNCT06733012

Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction

Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)


Sponsor

Duke University

Enrollment

54 participants

Start Date

Apr 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether blocking the splanchnic nerve (a nerve near the spine that controls blood flow to the abdominal organs) can reduce fluid buildup in the lungs and improve exercise tolerance in people with heart failure with reduced ejection fraction (HFrEF) — a type of heart failure where the heart muscle is weak. **You may be eligible if...** - You are over 18 years old - You have confirmed heart failure with a reduced ejection fraction (heart pumping less than 50%) - You have moderate symptoms (NYHA Class II or III) - Your heart failure medication regimen has been stable for at least 1 month - You have elevated pressures in your heart during rest or exercise (confirmed by a cardiac test) **You may NOT be eligible if...** - You had a heart attack in the past 3 months - You have a specific type of heart muscle disease (infiltrative or hypertrophic cardiomyopathy) - You have uncontrolled arrhythmia or require high-flow supplemental oxygen - You are pregnant or have an allergy to albumin - You have scoliosis or severe low blood pressure when standing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESplanchnic nerve block

Catheter based ablation on the right greater splanchnic nerve

OTHERSham-control procedure

Sham-control ablation procedure


Locations(1)

Duke

Durham, North Carolina, United States

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NCT06733012


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