Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University

Criteria

Inclusion Criteria:

• Followed at DUMC for known or suspected diagnosis of HF (NYHA stage 2-4, Class C-D), including patients on inotropic medication

• Systolic blood pressure (SBP) > 100 mmHg

• History of HF hospitalization or ER visit or iv diuretic use in last 12 months.

• Patients will be included regardless of left ventricular ejection fraction.

Exclusion Criteria:

• Anticoagulation at the time the procedure or in case of recent warfarin use an INR >1.4. Anticoagulation includes: warfarin, or novel oral anticoagulants like dabigatran, rivaroxaban, apixaban, endoxaban or full dose intravenous heparin products or bivalirudin and fondaparinux). Antiplatelet agents besides aspirin such as ticagrelor, prasugrel, Plavix are also considered to be a contraindication if used at time point of procedure.

• Immunosuppressive medications for solid organ transplant

• Acute MI (STEMI or Type I NSTEMI) within 7 days?

• Evidence of progressive cardiogenic shock within 48 hours

• Restrictive cardiomyopathy

• Constrictive pericarditis

• Pericardial effusion with evidence of tamponade

• Severe valvular stenosis requiring intervention

• Known history of an increased bleeding risk

• Thrombocytopenia (< 50,000)

• End-stage renal disease CKD stage 5 due to primary renal pathology