Splanchnic Nerve Anesthesia in Heart Failure

Study Overview
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Brief Summary
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Patients admitted for acute heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves. Patients will remain in the catheterization lab for the duration of anesthetic block and will be continuously hemodynamically monitored. This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.

Official Title
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Splanchnic Nerve Block for Acute Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: splanchnic nerve anesthesia with a local anesthetic
* Drug: regional nerve block with a local anesthetic (Lidocaine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of heart failure (HF) Prior admissions for decompensated HF Symptomatic with dyspnea with clinical, radiographic or echocardiographic signs of fluid overload On a stable HF drug regimen prior to admission Anticipated hospital stay of at least 2 nights following catheterization procedure Exclusion Criteria: Ongoing treatment with oral anticoagulation other than aspirin Immunosuppressive medications for solid organ transplant Acute MI (STEMI or NSTEMI) within 7 days Evidence of cardiogenic shock within 48 hours Systolic blood pressure < 90 mmHg or >180 mmHg Restrictive or constrictive cardiomyopathy Chronic kidney disease stage 3 or higher due to primary renal pathology Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regional nerve anesthesia<br>Regional nerve anesthesia of splanchnic nerve | Procedure: splanchnic nerve anesthesia with a local anesthetic<br>* regional nerve block of the splanchnic nerve<br>Drug: regional nerve block with a local anesthetic (Lidocaine)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Venous Pressure |  | Baseline, 90 minutes | 
| Pulmonary Arterial Mean Pressure |  | baseline, 30 minutes | 
| Pulmonary Capillary Wedge Pressure |  | baseline, 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Index |  | baseline, 30 minutes | 
| Ejection Fraction (LVEF) |  | Baseline, 90 minutes | 
| Pulmonary Artery Systolic Pressure |  | Baseline, 30 minutes | 
| Right Ventricular Diameter |  | Baseline, 30 mins | 
| Left Ventricular Diameter |  | Baseline, 30 mins | 
| N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level | NT-proBNP level is elevated in heart failure and reflects its severity. A higher value indicates less stability. | Baseline; 90 minutes | 
| Urine Output Measured in ml Over 3 Hours |  | Baseline, post-procedure (0-3 hours) | 
| Change in Blood Urea Nitrogen (BUN) | BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability. | Baseline; 90 minutes | 
| Change in Creatinine Level | Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability. | Baseline; 90 minutes | 
| Dyspnea as Measured on Likert Scale | The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change. | 15, 30, 45, 60, 75, 90 minutes; 24 hours | 
| Change in Clinical Symptoms, as Measured by 6 Minute Walk Test | The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Baseline, 90 minutes, 24 hours |