Actively Recruiting
Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction
Led by Duke University · Updated on 2026-05-05
54
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Established diagnosis of heart failure with reduced ejection fraction (left ventricular ejection fraction <50%)
- NYHA class II or III symptoms
- Stable heart failure medication regimen for at least 1 month
- Wedge pressure ≥ 15 mmHg at rest or ≥ 20 mmHg with peak stress on initial invasive exercise testing
- Glomerular filtration rate ≥ 15 mL/min per 1.73 m2
- Heart rate increases by at least 10 beats with activity such as a 6-minute walk
You will not qualify if you...
- Type I myocardial infarction within the past 3 months
- Infiltrative (e.g., amyloid) or hypertrophic cardiomyopathy
- Uncontrolled atrial (heart rate > 100 bpm) or ventricular arrhythmia
- Chronic oxygen use over 2 liters
- Hypersensitivity to albumin or pregnancy
- History of scoliosis
- Orthostatic hypotension, including a drop of pulse pressure with standing of more than 10
AI-Screening
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Trial Site Locations
Total: 1 location
1
Duke
Durham, North Carolina, United States, 27278
Actively Recruiting
Research Team
M
Marat Fudim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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