Splanchnic Nerve Anesthesia in Heart Failure

Duke University

Status: Completed

Conditions: Heart Failure

Treatments: Procedure: splanchnic nerve anesthesia with a local anesthetic; Drug: regional nerve block with a local anesthetic (Lidocaine)

Study type: Interventional

Funder types: Other

Identifiers

NCT02669407

Pro00066528

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Regional nerve anesthesia

Experimental group

Description:

Regional nerve anesthesia of splanchnic nerve

Treatment:

Procedure: splanchnic nerve anesthesia with a local anesthetic

Drug: regional nerve block with a local anesthetic (Lidocaine)