Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Splanchnic vasoconstriction may contribute to decompensation of chronic heart failure (HF)
      via volume redistribution from the splanchnic vascular bed to the central compartment. This
      is a sympathetically mediated reflex and can be interrupted through a splanchnic nerve block
      (SNB). We hypothesize that interruption of the efferent/afferent innervation of the
      splanchnic vasculature will decrease cardiac congestion in patients presenting with HF. Based
      on preliminary safety and efficacy data in acute and chronic heart failure patients with
      temporary (<24 h) SNB. Now we will apply a prolonged SNB in chronic heart failure patients
      using a long acting agent. We will test the effects of SNB on long term exercise capacitance.
    

Detailed description: 
      Activation of splanchnic nerves results in vasoconstriction and reduces splanchnic
      capacitance, therefore recruiting blood volume into the central circulation. In heart
      failure, a reduced splanchnic vascular capacitance could be the mechanism underlying symptoms
      of exercise intolerance and could predispose to rapid decompensation with external fluid
      intake or retention. A compromised vascular reservoir is likely unable to buffer shifts of
      fluid and actively contributes to the acute or chronic expulsion of fluid from the splanchnic
      vascular compartment to the central thoracic compartment. The redistribution of blood volume
      into the central circulation may lead to a sudden rise in pulmonary and left-sided cardiac
      pressures in HF. This makes the splanchnic vascular compartment an attractive target in heart
      failure. Our preliminary proof-of-concept work in patients with acute decompensated and
      chronic heart failure showed promise for the concept of splanchnic nerve modulation in heart
      failure. In a series of two small first-in-human studies for acute decompensated heart
      failure (N=13) (NCT02669407) and chronic heart failure (N=17) (NCT03453151), we found that a
      splanchnic nerve block (SNB) with lidocaine (90 min duration of action) and ropivacaine (24
      hours duration of action) acutely reduced resting and exercise-induced intra-cardiac filling
      pressures, associated with improved patient symptoms and functional capacity.

      The present study will be a prospective open-label pilot study to help establish feasibility,
      safety and enable dose finding for botulinumtoxin. Following a baseline invasive (right heart
      catheterization) cardiopulmonary exercise testing (CPX) patients will undergo unilateral
      celiac plexus block, followed by repeat hemodynamic testing. Functional testing at baseline
      and follow up will be supplemented by measures of blood volume and autonomic tone.
    

Intervention name(s): Splanchnic nerve block
Intervention type(s): Drug
Intervention description(s): Percutaneous splanchnic nerve block
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heart failure, exercise, splanchnic nerve block