Abdominal Nerve Blockade in Chronic Heart Failure.

Duke University19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

splanchnic nerve anesthesia with a local anestheticDRUG

regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)

Peak VO2 will be measured before and after nerve block.

Time frame: baseline, up to 1 hour

Mean Pulmonary Arterial Pressure (mPAP)

Mean pulmonary arterial pressure will be measured before and after nerve block.

Time frame: 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.

Time frame: baseline, up to 1 hour

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 2 hours pre-SNB, 2 hours post-SNB

Data from ClinicalTrials.gov

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