Abdominal Nerve Blockade in Chronic Heart Failure.

Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: splanchnic nerve anesthesia with a local anesthetic

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regional nerve anesthesia	Drug: splanchnic nerve anesthesia with a local anesthetic; regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Manesh Patel, Duke University

Publications and helpful links

General Publications

• Fudim M, Patel MR, Boortz-Marx R, Borlaug BA, DeVore AD, Ganesh A, Green CL, Lopes RD, Mentz RJ, Patel CB, Rogers JG, Felker GM, Hernandez AF, Sunagawa K, Burkhoff D. Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure. JACC Heart Fail. 2021 Apr;9(4):293-300. doi: 10.1016/j.jchf.2020.12.006. Epub 2021 Mar 10.
• Fudim M, Boortz-Marx RL, Ganesh A, DeVore AD, Patel CB, Rogers JG, Coburn A, Johnson I, Paul A, Coyne BJ, Rao SV, Gutierrez JA, Kiefer TL, Kong DF, Green CL, Jones WS, Felker GM, Hernandez AF, Patel MR. Splanchnic Nerve Block for Chronic Heart Failure. JACC Heart Fail. 2020 Sep;8(9):742-752. doi: 10.1016/j.jchf.2020.04.010. Epub 2020 Jun 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): June 27, 2019
• Study Completion (Actual): December 27, 2019

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: Pro00090299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No