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

NCT ID: NCT06733012

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-05
• Study Completion Date: 2029-05-01

Brief 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Splanchnic nerve ablation

Catheter based ablation on the right greater splanchnic nerve

Group Type: EXPERIMENTAL

Splanchnic nerve block

Intervention Type: DEVICE

Catheter based ablation on the right greater splanchnic nerve

Sham control

Sham-control procedure

Group Type: SHAM_COMPARATOR

Sham-control procedure

Intervention Type: OTHER

Sham-control ablation procedure

Interventions

Splanchnic nerve block

Catheter based ablation on the right greater splanchnic nerve

Intervention Type: DEVICE

Sham-control procedure

Sham-control ablation procedure

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marat Fudim

Role: CONTACT

marat.fudim@duke.edu

919-681-5816

Facility Contacts

Marat Fudim Asosciate Professor

Role: primary

marat.fudim@duke.edu

919-681-5816

Other Identifiers

PRO00114523

Identifier Type: -

Identifier Source: org_study_id