Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regional nerve anesthesia | Experimental | Regional nerve anesthesia of splanchnic nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| splanchnic nerve anesthesia with a local anesthetic | Procedure | regional nerve block of the splanchnic nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Venous Pressure | Baseline, 90 minutes | |
| Pulmonary Arterial Mean Pressure | baseline, 30 minutes | |
| Pulmonary Capillary Wedge Pressure | baseline, 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Index | baseline, 30 minutes | |
| Ejection Fraction (LVEF) | Baseline, 90 minutes | |
| Pulmonary Artery Systolic Pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33714749 | Derived | 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. |
Not provided
Not provided
Not provided
Recruited patients hospitalized for acute decompensated heart failure (ADHF) at Duke University Hospital between April 2017 and May 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Regional Nerve Anesthesia | Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Regional Nerve Anesthesia | Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine) |
| 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 | Central Venous Pressure | Participants who completed the study | Posted | Mean | Standard Deviation | mmHg | Baseline, 90 minutes |
|
|
48 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regional Nerve Anesthesia | Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marat Fudim, M.D. | Duke University | 919-684-8111 | marat.fudim@duke.edu |
Not provided
| 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 | Dec 22, 2017 | Oct 4, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| regional nerve block with a local anesthetic (Lidocaine) | Drug |
|
| Baseline, 30 minutes |
| Right Ventricular Diameter | Baseline, 30 mins |
| Left Ventricular Diameter | Baseline, 30 mins |
| 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. | Baseline; 90 minutes |
| Urine Output Measured in ml Over 3 Hours | Baseline, post-procedure (0-3 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. | Baseline; 90 minutes |
| Change in Creatinine Level | Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability. | Baseline; 90 minutes |
| Dyspnea as Measured on Likert Scale | The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change. | 15, 30, 45, 60, 75, 90 minutes; 24 hours |
| 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. | Baseline, 90 minutes, 24 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Central Venous Pressure | Mean | Standard Deviation | mmHg |
|
| Pulmonary Arterial Mean Pressure | Mean | Standard Deviation | mmHg |
|
| Pulmonary Capillary Wedge Pressure | Mean | Standard Deviation | mmHg |
|
|
| Primary | Pulmonary Arterial Mean Pressure | Participants who completed the study. | Posted | Mean | Standard Deviation | mmHg | baseline, 30 minutes |
|
|
|
|
| Primary | Pulmonary Capillary Wedge Pressure | Participants who completed the study. | Posted | Mean | Standard Deviation | mmHg | baseline, 30 minutes |
|
|
|
|
| Secondary | Cardiac Index | Participants who completed the study. | Posted | Mean | Standard Deviation | L/min/m^2 | baseline, 30 minutes |
|
|
|
|
| Secondary | Ejection Fraction (LVEF) | Participants who completed the study | Posted | Mean | Standard Deviation | percentage of ejected blood per contract | Baseline, 90 minutes |
|
|
|
| Secondary | Pulmonary Artery Systolic Pressure | Posted | Mean | Standard Deviation | mmHg | Baseline, 30 minutes |
|
|
|
| Secondary | Right Ventricular Diameter | Data not collected | Posted | Baseline, 30 mins |
|
|
| Secondary | Left Ventricular Diameter | Participants who completed the study | Posted | Median | Standard Deviation | cm | Baseline, 30 mins |
|
|
|
|
| Secondary | 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. | Participants who completed the study. | Posted | Median | Inter-Quartile Range | pg/dL | Baseline; 90 minutes |
|
|
|
|
| Secondary | Urine Output Measured in ml Over 3 Hours | Participants who completed the study. | Posted | Mean | Standard Deviation | ml over 3 hours | Baseline, post-procedure (0-3 hours) |
|
|
|
| Secondary | 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. | Participants who completed the study. | Posted | Median | Inter-Quartile Range | mg/dL | Baseline; 90 minutes |
|
|
|
|
| Secondary | Change in Creatinine Level | Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability. | Participants who completed the study. | Posted | Median | Inter-Quartile Range | mg/dL | Baseline; 90 minutes |
|
|
|
|
| Secondary | Dyspnea as Measured on Likert Scale | The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change. | Participants who completed the study. | Posted | Count of Participants | Participants | 15, 30, 45, 60, 75, 90 minutes; 24 hours |
|
|
|
| Secondary | 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. | Participants who completed the study. | Posted | Mean | Standard Deviation | meters | Baseline, 90 minutes, 24 hours |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
Not provided
Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |
|
| Left ventricular end systolic dimension; 30 mins |
|
| 0.586 |
| Other |
Single group |
| 0=No change |
|
| -1=Minimally worse |
|
| -2=Moderately worse |
|
| -3=Markedly worse |
|
| 30 minutes |
|
| 45 minutes |
|
| 60 minutes |
|
| 75 minutes |
|
| 90 minutes |
|
| 24 hours |
|
| 0.045 |
| Other |
Single group |