Home › Heart Failure › NCT06733012
Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction
Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)
Who can join
Ages 18 and older · All sexes
Full 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)
About the study
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.
What is being tested
- Splanchnic nerve block (device)
- Sham-control procedure (other)
Sponsor: Duke University · Participants: 54 · Started: Apr 5, 2025
Contact the study team
- Marat Fudim · Phone: 919-681-5816
Official record on ClinicalTrials.gov — NCT06733012
Locations in the U.S.
| North Carolina | Duke, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.