Trial Outcomes & Findings for Abdominal Nerve Blockade in Chronic Heart Failure. (NCT NCT03453151)

NCT ID: NCT03453151

Last Updated: 2020-07-24

Results Overview

Peak VO2 will be measured before and after nerve block.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: baseline, up to 1 hour
• Results posted on: 2020-07-24

Participant Flow

Participant milestones

Measure	Splanchnic Nerve Block (SNB) Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Overall Study STARTED	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Splanchnic Nerve Block (SNB) Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	3

Baseline Characteristics

Abdominal Nerve Blockade in Chronic Heart Failure.

Baseline characteristics by cohort

Measure	Splanchnic Nerve Block (SNB) n=15 Participants Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Age, Continuous	58 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants
N terminal pro BNP (B-type natriuretic peptide) level	2172 pmol/L n=5 Participants

PRIMARY outcome

Timeframe: baseline, up to 1 hour

Peak VO2 will be measured before and after nerve block.

Outcome measures

Measure	Splanchnic Nerve Block (SNB) n=15 Participants Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) Before nerve block	9.1 mL/kg/min Standard Deviation 2.5
Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) After nerve block	9.8 mL/kg/min Standard Deviation 2.7

PRIMARY outcome

Timeframe: baseline, up to 1 hour

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

Outcome measures

Measure	Splanchnic Nerve Block (SNB) n=15 Participants Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Mean Pulmonary Arterial Pressure (mPAP) Before nerve block	40.5 mmHg Standard Deviation 12.3
Mean Pulmonary Arterial Pressure (mPAP) After nerve block	32.7 mmHg Standard Deviation 13.8

PRIMARY outcome

Timeframe: baseline, up to 1 hour

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

Outcome measures

Measure	Splanchnic Nerve Block (SNB) n=15 Participants Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Pulmonary Capillary Wedge Pressure (PCWP) Peak exercise, before nerve block	34.8 mmHg Standard Deviation 10.0
Pulmonary Capillary Wedge Pressure (PCWP) Steady state, before nerve block	28.3 mmHg Standard Deviation 7.6
Pulmonary Capillary Wedge Pressure (PCWP) Steady state, after nerve block	20.3 mmHg Standard Deviation 9.5
Pulmonary Capillary Wedge Pressure (PCWP) Peak exercise, after nerve block	25.1 mmHg Standard Deviation 10.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Splanchnic Nerve Block (SNB) n=15 Participants Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Cardiac Index (CI) Steady state, before nerve block	1.9 L/min/m^2 Standard Deviation 0.6
Cardiac Index (CI) Steady state, after nerve block	2.3 L/min/m^2 Standard Deviation 0.7
Cardiac Index (CI) Peak exercise, before nerve block	3.4 L/min/m^2 Standard Deviation 1.2
Cardiac Index (CI) Peak exercise, after nerve block	3.8 L/min/m^2 Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Splanchnic Nerve Block (SNB) n=15 Participants Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Urine Output Before nerve block	167 mL Standard Deviation 174
Urine Output After nerve block	297 mL Standard Deviation 180

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Splanchnic Nerve Block (SNB) n=15 Participants Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Renal Biomarker Levels Creatinine, before nerve block	1.2 mg/dL Standard Deviation 0.4
Renal Biomarker Levels Creatinine, after nerve block	1.2 mg/dL Standard Deviation 0.4
Renal Biomarker Levels BUN, before nerve block	19 mg/dL Standard Deviation 10
Renal Biomarker Levels BUN, after nerve block	18 mg/dL Standard Deviation 10

Adverse Events

Splanchnic Nerve Block

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Splanchnic Nerve Block n=15 participants at risk Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 1 • 48 hours after SNB
Cardiac disorders Orthostasis	26.7% 4/15 • Number of events 4 • 48 hours after SNB

Additional Information

Marat Fudim

Duke University

Phone: (919) 681-5816

Email: marat.fudim@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place