Abdominal Nerve Blockade in Chronic Heart Failure.

Heart Failure Clinical Trial

Official title:

Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453151
• Other study ID #: Pro00090299
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 1, 2018
• Est. completion date: December 27, 2019

Study information

• Verified date: July 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• splanchnic nerve anesthesia with a local anesthetic
regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)

Locations

Country	Name	City	State
United States	Duke	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mean Pulmonary Arterial Pressure (mPAP)	Mean pulmonary arterial pressure will be measured before and after nerve block.	baseline, up to 1 hour
Primary	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	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
Secondary	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
Secondary	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