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

Duke University

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Sham-control procedure; Device: Splanchnic nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT06733012

PRO00114523

Details and patient eligibility

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Established diagnosis of HFrEF with left ventricular ejection fraction <50%
• NYHA II-III symptoms
• Stable HF drug regimen for the preceding 1 month
• Wedge pressure >/=15 mmHg at rest or >/=20 mmHg with peak stress on the initial invasive exercise testing
• Glomerular filtration rate ≥ 15 mL/min per 1.73 m2
• Heart rate with activity such as the 6 min walk increases by at least 10 beats

Exclusion criteria

• Type I myocardial infarction within 3 months
• Infiltrative (i.e., amyloid) or hypertrophic cardiomyopathy
• Uncontrolled atrial (heart rate >100bpm) or ventricular arrhythmia
• Chronic oxygen use >2L
• Hypersensitivity to albumin and pregnancy
• History or scoliosis
• Orthostatic hypotension (including a drop of pulse pressure with standing of more than 10)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups

Splanchnic nerve ablation

Experimental group

Description:

Catheter based ablation on the right greater splanchnic nerve

Treatment:

Device: Splanchnic nerve block

Sham control

Sham Comparator group

Description:

Sham-control procedure

Treatment:

Other: Sham-control procedure