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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06733012
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Splanchnic nerve block — DEVICE
    Catheter based ablation on the right greater splanchnic nerve
  • Sham-control procedure — OTHER
    Sham-control ablation procedure

Study Details

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.

Key Dates

Start date
Apr 5, 2025
Status verified
May 2026
Primary completion
Jan 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Splanchnic nerve ablation
    Catheter based ablation on the right greater splanchnic nerve
  • Sham Comparator: Sham control
    Sham-control procedure

Primary Outcome Measure

Number of participants with cardiovascular death [ Time Frame: 1 month post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
DukeDurhamNorth Carolina27278
Marat Fudim Asosciate Professor
[email protected]
919-681-5816

Find similar trials in Durham, NC

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Duke· Durham, NC

Related Studies