Heart Failure
Conditions
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.
Interventions
regional nerve block of the splanchnic nerve
DRUGregional nerve block with a local anesthetic (Lidocaine)
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Venous Pressure | Baseline, 90 minutes |
| Pulmonary Arterial Mean Pressure | baseline, 30 minutes |
| Pulmonary Capillary Wedge Pressure | baseline, 30 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Right Ventricular Diameter | Baseline, 30 mins | — |
| Left Ventricular Diameter | Baseline, 30 mins | — |
| N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level | Baseline; 90 minutes | 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 | Baseline, post-procedure (0-3 hours) | — |
| Cardiac Index | baseline, 30 minutes | — |
| Change in Creatinine Level | Baseline; 90 minutes | Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability. |
| Dyspnea as Measured on Likert Scale | 15, 30, 45, 60, 75, 90 minutes; 24 hours | 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 | Baseline, 90 minutes, 24 hours | 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. |
| Change in Blood Urea Nitrogen (BUN) | Baseline; 90 minutes | BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability. |
| Ejection Fraction (LVEF) | Baseline, 90 minutes | — |
| Pulmonary Artery Systolic Pressure | Baseline, 30 minutes | — |
Countries
United States
Participant flow
Recruitment details
Recruited patients hospitalized for acute decompensated heart failure (ADHF) at Duke University Hospital between April 2017 and May 2018.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Regional Nerve Anesthesia |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 13 |
| Central Venous Pressure | 18.73 mmHg STANDARD_DEVIATION 5.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Pulmonary Arterial Mean Pressure | 45.45 mmHg STANDARD_DEVIATION 5.99 |
| Pulmonary Capillary Wedge Pressure | 30 mmHg STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Central Venous Pressure
Time frame: Baseline, 90 minutes
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Central Venous Pressure | Baseline | 18.73 mmHg | Standard Deviation 5.57 |
| Regional Nerve Anesthesia | Central Venous Pressure | 90 minutes | 14.91 mmHg | Standard Deviation 5.24 |
Primary
Pulmonary Arterial Mean Pressure
Time frame: baseline, 30 minutes
Population: Participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Pulmonary Arterial Mean Pressure | Baseline | 45.45 mmHg | Standard Deviation 5.99 |
| Regional Nerve Anesthesia | Pulmonary Arterial Mean Pressure | 30 minutes | 37.64 mmHg | Standard Deviation 7.03 |
p-value: <0.001Tukey's method
Primary
Pulmonary Capillary Wedge Pressure
Time frame: baseline, 30 minutes
Population: Participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Pulmonary Capillary Wedge Pressure | Baseline | 30 mmHg | Standard Deviation 7 |
| Regional Nerve Anesthesia | Pulmonary Capillary Wedge Pressure | 30 minutes | 22 mmHg | Standard Deviation 7 |
Comparison: Baseline, 30 minutesp-value: 0.001Tukey's method
Secondary
Cardiac Index
Time frame: baseline, 30 minutes
Population: Participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Cardiac Index | Baseline | 2.17 L/min/m^2 | Standard Deviation 0.74 |
| Regional Nerve Anesthesia | Cardiac Index | 30 minutes | 2.59 L/min/m^2 | Standard Deviation 0.65 |
Comparison: baseline, 30 minutesp-value: 0.007Tukey's method
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.
Time frame: Baseline; 90 minutes
Population: Participants who completed the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Regional Nerve Anesthesia | Change in Blood Urea Nitrogen (BUN) | Baseline | 61 mg/dL |
| Regional Nerve Anesthesia | Change in Blood Urea Nitrogen (BUN) | 90 minutes | 53 mg/dL |
p-value: 0.061t-test, 2 sided
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.
Time frame: Baseline, 90 minutes, 24 hours
Population: Participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Change in Clinical Symptoms, as Measured by 6 Minute Walk Test | Baseline, 90 minutes | 8.7 meters | Standard Deviation 51.6 |
| Regional Nerve Anesthesia | Change in Clinical Symptoms, as Measured by 6 Minute Walk Test | Baseline, 24 hours | 24.7 meters | Standard Deviation 31.2 |
Comparison: Baseline, 90 minutesp-value: 0.606t-test, 2 sided
Comparison: Baseline, 24 hoursp-value: 0.045t-test, 2 sided
Secondary
Change in Creatinine Level
Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.
Time frame: Baseline; 90 minutes
Population: Participants who completed the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Regional Nerve Anesthesia | Change in Creatinine Level | Baseline | 2.1 mg/dL |
| Regional Nerve Anesthesia | Change in Creatinine Level | 90 minutes | 1.9 mg/dL |
p-value: 0.787t-test, 2 sided
Secondary
Dyspnea as Measured on Likert Scale
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
Population: Participants who completed the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 15 minutes | 3=Markedly improved | 2 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 15 minutes | 2=Moderately Improved | 1 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 15 minutes | 1=Minimally improved | 4 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 15 minutes | 0=No change | 4 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 15 minutes | -1=Minimally worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 15 minutes | -2=Moderately worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 15 minutes | -3=Markedly worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 30 minutes | 3=Markedly improved | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 30 minutes | 2=Moderately Improved | 3 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 30 minutes | 1=Minimally improved | 5 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 30 minutes | 0=No change | 2 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 30 minutes | -1=Minimally worse | 1 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 30 minutes | -2=Moderately worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 30 minutes | -3=Markedly worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 45 minutes | 3=Markedly improved | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 45 minutes | 2=Moderately Improved | 3 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 45 minutes | 1=Minimally improved | 7 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 45 minutes | 0=No change | 1 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 45 minutes | -1=Minimally worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 45 minutes | -2=Moderately worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 45 minutes | -3=Markedly worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 60 minutes | 3=Markedly improved | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 60 minutes | 2=Moderately Improved | 1 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 60 minutes | 1=Minimally improved | 5 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 60 minutes | 0=No change | 4 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 60 minutes | -1=Minimally worse | 1 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 60 minutes | -3=Markedly worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 75 minutes | 3=Markedly improved | 1 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 75 minutes | 2=Moderately Improved | 2 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 75 minutes | 1=Minimally improved | 3 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 75 minutes | 0=No change | 5 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 75 minutes | -1=Minimally worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 75 minutes | -2=Moderately worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 75 minutes | -3=Markedly worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 90 minutes | 3=Markedly improved | 3 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 90 minutes | 2=Moderately Improved | 2 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 90 minutes | 1=Minimally improved | 3 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 90 minutes | 0=No change | 3 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 90 minutes | -1=Minimally worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 90 minutes | -2=Moderately worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 90 minutes | -3=Markedly worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 24 hours | 3=Markedly improved | 3 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 24 hours | 2=Moderately Improved | 2 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 24 hours | 1=Minimally improved | 5 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 24 hours | 0=No change | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 24 hours | -1=Minimally worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 24 hours | -2=Moderately worse | 0 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 24 hours | -3=Markedly worse | 1 Participants |
| Regional Nerve Anesthesia | Dyspnea as Measured on Likert Scale | 60 minutes | -2=Moderately worse | 0 Participants |
Secondary
Ejection Fraction (LVEF)
Time frame: Baseline, 90 minutes
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Ejection Fraction (LVEF) | Baseline | 18.27 percentage of ejected blood per contract | Standard Deviation 11.18 |
| Regional Nerve Anesthesia | Ejection Fraction (LVEF) | 90 minutes | 19.4 percentage of ejected blood per contract | Standard Deviation 10.32 |
Secondary
Left Ventricular Diameter
Time frame: Baseline, 30 mins
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Left Ventricular Diameter | Left ventricular end diastolic dimension; Baseline | 6.2 cm | Standard Deviation 1 |
| Regional Nerve Anesthesia | Left Ventricular Diameter | Left ventricular end diastolic dimension; 30 mins | 6.1 cm | Standard Deviation 0.9 |
| Regional Nerve Anesthesia | Left Ventricular Diameter | Left ventricular end systolic dimension; Baseline | 5.4 cm | Standard Deviation 1.3 |
| Regional Nerve Anesthesia | Left Ventricular Diameter | Left ventricular end systolic dimension; 30 mins | 5.4 cm | Standard Deviation 1.3 |
Comparison: Change in left ventricular end diastolic dimensionp-value: 0.237t-test, 2 sided
Comparison: Change in left ventricular end systolic dimensionp-value: 0.586t-test, 2 sided
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.
Time frame: Baseline; 90 minutes
Population: Participants who completed the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Regional Nerve Anesthesia | N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level | Baseline | 4,297 pg/dL |
| Regional Nerve Anesthesia | N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level | 90 minutes | 2,936 pg/dL |
p-value: 0.175t-test, 2 sided
Secondary
Pulmonary Artery Systolic Pressure
Time frame: Baseline, 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Pulmonary Artery Systolic Pressure | Baseline | 65.18 mmHg | Standard Deviation 9.95 |
| Regional Nerve Anesthesia | Pulmonary Artery Systolic Pressure | 30 minutes | 53.91 mmHg | Standard Deviation 12.47 |
Secondary
Right Ventricular Diameter
Time frame: Baseline, 30 mins
Population: Data not collected
Secondary
Urine Output Measured in ml Over 3 Hours
Time frame: Baseline, post-procedure (0-3 hours)
Population: Participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Nerve Anesthesia | Urine Output Measured in ml Over 3 Hours | Baseline | 138.09 ml over 3 hours | Standard Deviation 92.22 |
| Regional Nerve Anesthesia | Urine Output Measured in ml Over 3 Hours | post-procedure 0-3 hours | 258.64 ml over 3 hours | Standard Deviation 199.22 |