Abdominal Nerve Blockade in Chronic Heart Failure.

Study Overview
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Brief Summary
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Patients with chronic 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. 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. Patients will undergo detailed physiological testing.

Official Title
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Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: splanchnic nerve anesthesia with a local anesthetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of heart failure (HF) Symptomatic with dyspnea On a stable HF drug regimen Exclusion Criteria: Ongoing treatment with oral anticoagulation other than aspirin Immunosuppressive medications for solid organ transplant Acute MI (STEMI or Type I NSTEMI) within 7 days Systolic blood pressure < 90 mmHg or >180 mmHg Infiltrative cardiomyopathy or constrictive cardiomyopathy Chronic kidney disease stage 5 Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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> | Drug: splanchnic nerve anesthesia with a local anesthetic<br>* regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) | Peak VO2 will be measured before and after nerve block. | baseline, up to 1 hour | 
| Mean Pulmonary Arterial Pressure (mPAP) | Mean pulmonary arterial pressure will be measured before and after nerve block. | baseline, up to 1 hour | 
| Pulmonary Capillary Wedge Pressure (PCWP) | Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise. | baseline, up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Index (CI) | Cardiac index will be measured at 20 Watts steady state and peak exercise. Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA), thus relating heart performance to the size of the individual. | baseline, up to 1 hour | 
| Urine Output | Urine output will be measured in the 2 hours before the nerve block and in the 2 hours afterwards | 2 hours pre-SNB, 2 hours post-SNB | 
| Renal Biomarker Levels | BUN (blood urea nitrogen) and creatinine levels will be measured in the 2 hours before the nerve block and in the 2 hours afterwards. | 2 hours pre-SNB, 2 hours post-SNB |