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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regional nerve anesthesia | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| splanchnic nerve anesthesia with a local anesthetic | Drug | regional nerve block with a local anesthetic (Lidocaine/Bupivacaine) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manesh Patel | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37449573 | Derived | Kittipibul V, Ganesh A, Coburn A, Coyne BJ, Gray JM, Molinger J, Ray N, Podgoreanu M, McCartney SL, Mamoun N, Fitzhugh RC, Lurz P, Green CL, Hernandez AF, Patel MR, Fudim M. Splanchnic Nerve Modulation Effects on Surrogate Measures of Venous Capacitance. J Am Heart Assoc. 2023 Jul 18;12(14):e028780. doi: 10.1161/JAHA.122.028780. Epub 2023 Jul 14. | |
| 33714749 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Splanchnic Nerve Block (SNB) | Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Splanchnic Nerve Block (SNB) | Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) | Peak VO2 will be measured before and after nerve block. | Posted | Mean | Standard Deviation | mL/kg/min | baseline, up to 1 hour |
|
|
48 hours after SNB
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Splanchnic Nerve Block | Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea for <24 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marat Fudim | Duke University | (919) 681-5816 | marat.fudim@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2020 | Jun 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| 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. |
| 32535123 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| N terminal pro BNP (B-type natriuretic peptide) level | Mean | Full Range | pmol/L |
|
|
|
| Primary | Mean Pulmonary Arterial Pressure (mPAP) | Mean pulmonary arterial pressure will be measured before and after nerve block. | Posted | Mean | Standard Deviation | mmHg | 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. | Posted | Mean | Standard Deviation | mmHg | 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. | Posted | Mean | Standard Deviation | L/min/m^2 | 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 | Posted | Mean | Standard Deviation | mL | 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. | Posted | Mean | Standard Deviation | mg/dL | 2 hours pre-SNB, 2 hours post-SNB |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 5 |
| 15 |
| Orthostasis | Cardiac disorders | Systematic Assessment | The first five patients had bilateral SNB and four of them developed symptomatic orthostatic hypotension (systolic blood pressure drop >20mmHg with 5 min standing). In all cases the orthostatic hypotension resolved with oral or intravenous hydration |
|
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|
| Peak exercise, after nerve block |
|
| Title | Measurements |
|---|---|
|
| Peak exercise, after nerve block |
|
| 0.069 |
| Other |
|
| BUN, after nerve block |
|
| 0.014 |
| Other |