Phase 2
N=4
Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)
Chronic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04575428 ↗Enrolled (actual)
4
Serious AEs
25.0%
Results posted
Jun 2023
Primary outcome: Primary: Peak Exercise Wedge Pressure — 44; 34 Mmhg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Splanchnic nerve block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Exercise Wedge Pressure |
44; 34 | — |
| PRIMARY Peak Pulmonary Arterial Pressure |
56; 47 | — |
| PRIMARY Absence of Nerve Block Related Complications |
— | — |
| SECONDARY Peak Oxygen Uptake |
10.5; 9.1 | — |
| SECONDARY Resting Wedge Pressure |
17.5; 14 | — |
| SECONDARY Resting Central Venous Pressure |
9.3; 5.8 | — |
| SECONDARY Resting Pulmonary Arterial Pressure |
24; 20 | — |
| SECONDARY Dyspnea - Visual Analog Scale (VAS) |
76; 81 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04575428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.