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

NCT06733012 | Recruiting FDA Device

• 1 other identifier: PRO00114523
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Number of participants with cardiovascular death

  1 month post intervention

• Number of participants with acute myocardial infarction

  1 month post intervention

• Number of participants with major vascular complications resulting prolonged hospitalization or surgical intervention

  1 month post intervention

• Number of participants with stroke

  1 month post intervention

• Change in exercise pulmonary capillary wedge pressure (PCWP) post splanchnic nerve block (SNB)

  Pulmonary capillary wedge pressure (PCWP) is measured by inserting a catheter with a balloon tip into a central vein and advancing it into a branch of the pulmonary artery. The catheter measures changing pressures in the pulmonary vessels. The upper limit of normal for PCWP is 12 mm Hg.

  Baseline to 3 months post splanchnic nerve block (SNB)

Secondary Outcomes (8)

• Change in pulmonary arterial mean pressure

  Baseline to 3 months

• Change in peak VO2 (oxygen uptake)

  Baseline, 1, 3, 6, and 12 months

• Change in 6-minute walk test (6MWT)

  Baseline, 1, 3, 6, and 12 months

• Change in N terminal pro brain natriuretic protein (NT-proBNP) level

  Baseline, 1, 3, 6, and 12 months

• Change in echocardiographic parameters - ejection fraction (EF)

  Baseline, 1, 3, and 6 months

Study Arms (2)

Splanchnic nerve ablation

EXPERIMENTAL

Catheter based ablation on the right greater splanchnic nerve

Device: Splanchnic nerve block

Sham control

SHAM COMPARATOR

Sham-control procedure

Other: Sham-control procedure

Interventions

Splanchnic nerve block DEVICE

Catheter based ablation on the right greater splanchnic nerve

Splanchnic nerve ablation

Sham-control procedure OTHER

Sham-control ablation procedure

Sham control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke

Durham, North Carolina, 27278, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Manesh Patel, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marat Fudim

CONTACT

919-681-5816; marat.fudim@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 13, 2024
• Study Start: April 5, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)