Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06733012

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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