Heart Failure
Conditions
Brief 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.
Interventions
regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of heart failure (HF) * Symptomatic with dyspnea * On a stable HF drug regimen
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Capillary Wedge Pressure (PCWP) | baseline, up to 1 hour | Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise. |
| Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) | baseline, up to 1 hour | Peak VO2 will be measured before and after nerve block. |
| Mean Pulmonary Arterial Pressure (mPAP) | baseline, up to 1 hour | Mean pulmonary arterial pressure will be measured before and after nerve block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Index (CI) | baseline, up to 1 hour | 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. |
| Urine Output | 2 hours pre-SNB, 2 hours post-SNB | Urine output will be measured in the 2 hours before the nerve block and in the 2 hours afterwards |
| Renal Biomarker Levels | 2 hours pre-SNB, 2 hours post-SNB | BUN (blood urea nitrogen) and creatinine levels will be measured in the 2 hours before the nerve block and in the 2 hours afterwards. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Splanchnic Nerve Block (SNB) Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine) | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Splanchnic Nerve Block (SNB) |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 13 |
| N terminal pro BNP (B-type natriuretic peptide) level | 2172 pmol/L |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 12 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 5 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Splanchnic Nerve Block (SNB) | Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) | Before nerve block | 9.1 mL/kg/min | Standard Deviation 2.5 |
| Splanchnic Nerve Block (SNB) | Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) | After nerve block | 9.8 mL/kg/min | Standard Deviation 2.7 |
p-value: 0.053Paired t-test
Primary
Mean Pulmonary Arterial Pressure (mPAP)
Mean pulmonary arterial pressure will be measured before and after nerve block.
Time frame: baseline, up to 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Splanchnic Nerve Block (SNB) | Mean Pulmonary Arterial Pressure (mPAP) | Before nerve block | 40.5 mmHg | Standard Deviation 12.3 |
| Splanchnic Nerve Block (SNB) | Mean Pulmonary Arterial Pressure (mPAP) | After nerve block | 32.7 mmHg | Standard Deviation 13.8 |
p-value: <0.001Paired t-test
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Splanchnic Nerve Block (SNB) | Pulmonary Capillary Wedge Pressure (PCWP) | Steady state, before nerve block | 28.3 mmHg | Standard Deviation 7.6 |
| Splanchnic Nerve Block (SNB) | Pulmonary Capillary Wedge Pressure (PCWP) | Steady state, after nerve block | 20.3 mmHg | Standard Deviation 9.5 |
| Splanchnic Nerve Block (SNB) | Pulmonary Capillary Wedge Pressure (PCWP) | Peak exercise, before nerve block | 34.8 mmHg | Standard Deviation 10 |
| Splanchnic Nerve Block (SNB) | Pulmonary Capillary Wedge Pressure (PCWP) | Peak exercise, after nerve block | 25.1 mmHg | Standard Deviation 10.7 |
p-value: <0.001Paired t-test
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.
Time frame: baseline, up to 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Splanchnic Nerve Block (SNB) | Cardiac Index (CI) | Steady state, before nerve block | 1.9 L/min/m^2 | Standard Deviation 0.6 |
| Splanchnic Nerve Block (SNB) | Cardiac Index (CI) | Steady state, after nerve block | 2.3 L/min/m^2 | Standard Deviation 0.7 |
| Splanchnic Nerve Block (SNB) | Cardiac Index (CI) | Peak exercise, before nerve block | 3.4 L/min/m^2 | Standard Deviation 1.2 |
| Splanchnic Nerve Block (SNB) | Cardiac Index (CI) | Peak exercise, after nerve block | 3.8 L/min/m^2 | Standard Deviation 1.1 |
p-value: 0.077Paired t-test
p-value: 0.069Paired t-test
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.
Time frame: 2 hours pre-SNB, 2 hours post-SNB
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Splanchnic Nerve Block (SNB) | Renal Biomarker Levels | Creatinine, before nerve block | 1.2 mg/dL | Standard Deviation 0.4 |
| Splanchnic Nerve Block (SNB) | Renal Biomarker Levels | Creatinine, after nerve block | 1.2 mg/dL | Standard Deviation 0.4 |
| Splanchnic Nerve Block (SNB) | Renal Biomarker Levels | BUN, before nerve block | 19 mg/dL | Standard Deviation 10 |
| Splanchnic Nerve Block (SNB) | Renal Biomarker Levels | BUN, after nerve block | 18 mg/dL | Standard Deviation 10 |
p-value: 0.25Paired t-test
p-value: 0.014Paired t-test
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Splanchnic Nerve Block (SNB) | Urine Output | Before nerve block | 167 mL | Standard Deviation 174 |
| Splanchnic Nerve Block (SNB) | Urine Output | After nerve block | 297 mL | Standard Deviation 180 |