Recruiting

Splanchnic Nerve Block

Sponsor:

Duke University

Code:

NCT06733012

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Splanchnic nerve block

Sham-control procedure

Study Details

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 ID

NCT06733012

Start date

Apr 5, 2025

Status verified date

May, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Splanchnic nerve ablation

Catheter based ablation on the right greater splanchnic nerve

sham comparator: Sham control

Sham-control procedure

Interventions

Splanchnic nerve block

Catheter based ablation on the right greater splanchnic nerve

Sham-control procedure

Sham-control ablation procedure

Primary outcome measure

  • Number of participants with cardiovascular death [ Time Frame: 1 month post intervention ]
  • Number of participants with acute myocardial infarction [ Time Frame: 1 month post intervention ]
  • Number of participants with major vascular complications resulting prolonged hospitalization or surgical intervention [ Time Frame: 1 month post intervention ]
  • Number of participants with stroke [ Time Frame: 1 month post intervention ]
  • Change in exercise pulmonary capillary wedge pressure (PCWP) post splanchnic nerve block (SNB) [ Time Frame: Baseline to 3 months post splanchnic nerve block (SNB) ]

Central Contacts and Locations

Central contacts

Locations

Duke

Recruiting

Durham, North Carolina, United States, 27278

Contacts

Marat Fudim Asosciate Professor

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

More Information

Sponsor

Duke University

Last update posted

May 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-05.