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Splanchnic Nerve Anesthesia in Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
splanchnic nerve anesthesia with a local anesthetic
regional nerve block with a local anesthetic (Lidocaine)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regional nerve anesthesia

Arm Description

Regional nerve anesthesia of splanchnic nerve

Outcomes

Primary Outcome Measures

Central Venous Pressure
Pulmonary Arterial Mean Pressure
Pulmonary Capillary Wedge Pressure

Secondary Outcome Measures

Cardiac Index
Ejection Fraction (LVEF)
Pulmonary Artery Systolic Pressure
Right Ventricular Diameter
Left Ventricular Diameter
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level
NT-proBNP level is elevated in heart failure and reflects its severity. A higher value indicates less stability.
Urine Output Measured in ml Over 3 Hours
Change in Blood Urea Nitrogen (BUN)
BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability.
Change in Creatinine Level
Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.
Dyspnea as Measured on Likert Scale
The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change.
Change in Clinical Symptoms, as Measured by 6 Minute Walk Test
The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Full Information

First Posted
January 22, 2016
Last Updated
November 19, 2019
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02669407
Brief Title
Splanchnic Nerve Anesthesia in Heart Failure
Official Title
Splanchnic Nerve Block for Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regional nerve anesthesia
Arm Type
Experimental
Arm Description
Regional nerve anesthesia of splanchnic nerve
Intervention Type
Procedure
Intervention Name(s)
splanchnic nerve anesthesia with a local anesthetic
Intervention Description
regional nerve block of the splanchnic nerve
Intervention Type
Drug
Intervention Name(s)
regional nerve block with a local anesthetic (Lidocaine)
Primary Outcome Measure Information:
Title
Central Venous Pressure
Time Frame
Baseline, 90 minutes
Title
Pulmonary Arterial Mean Pressure
Time Frame
baseline, 30 minutes
Title
Pulmonary Capillary Wedge Pressure
Time Frame
baseline, 30 minutes
Secondary Outcome Measure Information:
Title
Cardiac Index
Time Frame
baseline, 30 minutes
Title
Ejection Fraction (LVEF)
Time Frame
Baseline, 90 minutes
Title
Pulmonary Artery Systolic Pressure
Time Frame
Baseline, 30 minutes
Title
Right Ventricular Diameter
Time Frame
Baseline, 30 mins
Title
Left Ventricular Diameter
Time Frame
Baseline, 30 mins
Title
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level
Description
NT-proBNP level is elevated in heart failure and reflects its severity. A higher value indicates less stability.
Time Frame
Baseline; 90 minutes
Title
Urine Output Measured in ml Over 3 Hours
Time Frame
Baseline, post-procedure (0-3 hours)
Title
Change in Blood Urea Nitrogen (BUN)
Description
BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability.
Time Frame
Baseline; 90 minutes
Title
Change in Creatinine Level
Description
Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.
Time Frame
Baseline; 90 minutes
Title
Dyspnea as Measured on Likert Scale
Description
The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change.
Time Frame
15, 30, 45, 60, 75, 90 minutes; 24 hours
Title
Change in Clinical Symptoms, as Measured by 6 Minute Walk Test
Description
The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time Frame
Baseline, 90 minutes, 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Duke
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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

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Splanchnic Nerve Anesthesia in Heart Failure

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