NCT06733012Recruiting
Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction
Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 4 Dec 2024
- Start date
- 5 Apr 2025
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Duke University
- Diseases
- Heart failure
- NCT number
- NCT06733012
What you commit to
- Study type: Interventional
- Planned participants: 54
- From 5 Apr 2025 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type I myocardial infarction within 3 months
- Uncontrolled atrial (heart rate \>100bpm) or ventricular arrhythmia
Lab values
- Hypersensitivity to albumin and pregnancy
Other
- Infiltrative (i.e., amyloid) or hypertrophic cardiomyopathy
- Chronic oxygen use \>2L
- History or scoliosis
- Orthostatic hypotension (including a drop of pulse pressure with standing of more than 10)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.