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RECRUITING
NCT06733012
NA

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

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Official title: Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-04-05

Completion Date

2029-05-01

Last Updated

2025-04-17

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Splanchnic nerve block

Catheter based ablation on the right greater splanchnic nerve

OTHER

Sham-control procedure

Sham-control ablation procedure

Locations (1)

Duke

Durham, North Carolina, United States