Abdominal Nerve Blockade in Chronic Heart Failure.

Duke University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Heart Failure

Treatments: Drug: splanchnic nerve anesthesia with a local anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT03453151

Pro00090299

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Regional nerve anesthesia

Experimental group

Treatment:

Drug: splanchnic nerve anesthesia with a local anesthetic