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CompletedNCT03453151Updated Jul 24, 2020Results posted

Abdominal Nerve Blockade in Chronic Heart Failure.

A Phase 1/2 interventional study of splanchnic nerve anesthesia with a local anesthetic in Heart Failure, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-24.

Sponsored by Duke University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of heart failure (HF)
  • Symptomatic with dyspnea
  • On a stable HF drug regimen

Exclusion criteria

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Regional nerve anesthesia

    Drug: splanchnic nerve anesthesia with a local anesthetic

Interventions

  • Drugsplanchnic nerve anesthesia with a local anesthetic

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

05

What researchers measure

Primary outcomes

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

    Peak VO2 will be measured before and after nerve block.

    Time frame: baseline, up to 1 hour

  2. Mean Pulmonary Arterial Pressure (mPAP)

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

    Time frame: baseline, up to 1 hour

  3. Pulmonary Capillary Wedge Pressure (PCWP)

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

    Time frame: baseline, up to 1 hour

Secondary outcomes

  1. 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.

    Time frame: baseline, up to 1 hour

  2. Urine Output

    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

  3. 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.

    Time frame: 2 hours pre-SNB, 2 hours post-SNB

06

Results

Posted Jul 24, 2020

Participant flow

Participant flow — Overall Study
MilestoneSplanchnic Nerve Block (SNB)
Started19
Completed15
Not completed4
Withdrew: Withdrawal by subject1
Withdrew: Physician decision3

Outcome measures

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

Peak VO2 will be measured before and after nerve block.

Time frame:
baseline, up to 1 hour
Reported as:
Mean · mL/kg/min
Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)
mL/kg/minSplanchnic Nerve Block (SNB)
Before nerve block9.1 ± 2.5
After nerve block9.8 ± 2.7
Statistical analysis
  • Splanchnic Nerve Block (SNB) · Paired t-test · p = 0.053
PrimaryMean Pulmonary Arterial Pressure (mPAP)

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

Time frame:
baseline, up to 1 hour
Reported as:
Mean · mmHg
Mean Pulmonary Arterial Pressure (mPAP)
mmHgSplanchnic Nerve Block (SNB)
Before nerve block40.5 ± 12.3
After nerve block32.7 ± 13.8
Statistical analysis
  • Splanchnic Nerve Block (SNB) · Paired t-test · p = <0.001
PrimaryPulmonary Capillary Wedge Pressure (PCWP)

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

Time frame:
baseline, up to 1 hour
Reported as:
Mean · mmHg
Pulmonary Capillary Wedge Pressure (PCWP)
mmHgSplanchnic Nerve Block (SNB)
Steady state, before nerve block28.3 ± 7.6
Steady state, after nerve block20.3 ± 9.5
Peak exercise, before nerve block34.8 ± 10.0
Peak exercise, after nerve block25.1 ± 10.7
Statistical analysis
  • Splanchnic Nerve Block (SNB) · Paired t-test · p = <0.001
SecondaryCardiac 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.

Time frame:
baseline, up to 1 hour
Reported as:
Mean · L/min/m^2
Cardiac Index (CI)
L/min/m^2Splanchnic Nerve Block (SNB)
Steady state, before nerve block1.9 ± 0.6
Steady state, after nerve block2.3 ± 0.7
Peak exercise, before nerve block3.4 ± 1.2
Peak exercise, after nerve block3.8 ± 1.1
Statistical analysis
  • Splanchnic Nerve Block (SNB) · Paired t-test · p = 0.077This analysis refers to the resting cardiac index.
  • Splanchnic Nerve Block (SNB) · Paired t-test · p = 0.069This analysis refers to the peak exercise cardiac index.
SecondaryUrine Output

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
Reported as:
Mean · mL
Urine Output
mLSplanchnic Nerve Block (SNB)
Before nerve block167 ± 174
After nerve block297 ± 180
SecondaryRenal 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.

Time frame:
2 hours pre-SNB, 2 hours post-SNB
Reported as:
Mean · mg/dL
Renal Biomarker Levels
mg/dLSplanchnic Nerve Block (SNB)
Creatinine, before nerve block1.2 ± 0.4
Creatinine, after nerve block1.2 ± 0.4
BUN, before nerve block19 ± 10
BUN, after nerve block18 ± 10
Statistical analysis
  • Splanchnic Nerve Block (SNB) · Paired t-test · p = 0.250This analysis refers to creatinine level.
  • Splanchnic Nerve Block (SNB) · Paired t-test · p = 0.014This analysis refers to BUN level.

Adverse events

Collected over 48 hours after SNB. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Splanchnic Nerve Block0/15 (0%)0/15 (0%)5/15 (33.3%)
Most frequent other events
Most frequent other events
EventSplanchnic Nerve Block
OrthostasisCardiac disorders4/15
DiarrheaGastrointestinal disorders1/15

Baseline characteristics

Participants who completed the study.

Age, Continuous
Age, Continuous(years)Splanchnic Nerve Block (SNB)
Mean58 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)Splanchnic Nerve Block (SNB)
Female7
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Splanchnic Nerve Block (SNB)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White12
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Splanchnic Nerve Block (SNB)
United States15
N terminal pro BNP (B-type natriuretic peptide) level
N terminal pro BNP (B-type natriuretic peptide) level(pmol/L)Splanchnic Nerve Block (SNB)
Mean2172 (112 to 9319)
07

Study locations

1 site
  • Duke
    Durham, North Carolina 27710, United States
08

References and documents

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. PubMed 33714749 ↗
  • 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. PubMed 32535123 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 2, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03453151
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
May 1, 2018
Primary completion
Jun 27, 2019
Completion
Dec 27, 2019
Results posted
Jul 24, 2020
Last update
Jul 24, 2020

Study contacts

Manesh Patel
principal investigator · Duke University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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