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Abdominal Nerve Blockade in Chronic Heart Failure.

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

splanchnic nerve anesthesia with a local anesthetic

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Duke

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regional nerve anesthesia

Arm Description

Outcomes

Primary Outcome Measures

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

Peak VO2 will be measured before and after nerve block.

Mean Pulmonary Arterial Pressure (mPAP)

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

Pulmonary Capillary Wedge Pressure (PCWP)

Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.

Secondary Outcome Measures

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.

Urine Output

Urine output will be measured in the 2 hours before the nerve block and in the 2 hours afterwards

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.

Full Information

NCT ID

NCT03453151

First Posted

February 20, 2018

Last Updated

July 23, 2020

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03453151

Brief Title

Abdominal Nerve Blockade in Chronic Heart Failure.

Official Title

Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

June 27, 2019 (Actual)

Study Completion Date

December 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regional nerve anesthesia

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

splanchnic nerve anesthesia with a local anesthetic

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Peak VO2 will be measured before and after nerve block.

Time Frame

baseline, up to 1 hour

Title

Mean Pulmonary Arterial Pressure (mPAP)

Description

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

Time Frame

baseline, up to 1 hour

Title

Pulmonary Capillary Wedge Pressure (PCWP)

Description

Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.

Time Frame

baseline, up to 1 hour

Secondary Outcome Measure Information:

Title

Cardiac Index (CI)

Description

Time Frame

baseline, up to 1 hour

Title

Urine Output

Description

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

Title

Renal Biomarker Levels

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manesh Patel

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33714749

Citation

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.

Results Reference

derived

PubMed Identifier

32535123

Citation

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.

Results Reference

derived

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Abdominal Nerve Blockade in Chronic Heart Failure.

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