Trial Outcomes & Findings for Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III) (NCT NCT04575428)

NCT ID: NCT04575428

Last Updated: 2023-06-27

Results Overview

Measured with cardiopulmonary exercise testing

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2023-06-27

Participant Flow

Participant milestones

Measure	Splanchnic Nerve Block Splanchnic nerve block: Percutaneous splanchnic nerve block
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)

Baseline characteristics by cohort

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Age, Continuous	73 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	4 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
Left ventricular ejection fraction >55%	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Measured with cardiopulmonary exercise testing

Outcome measures

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Peak Exercise Wedge Pressure Pre nerve block	44 Mmhg Standard Deviation 6.2
Peak Exercise Wedge Pressure Post nerve block	34 Mmhg Standard Deviation 8.2

PRIMARY outcome

Timeframe: 4 weeks

Measured on exercise cardiopulmonary stress test

Outcome measures

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Peak Pulmonary Arterial Pressure Baseline	56 Mmhg Standard Deviation 9.2
Peak Pulmonary Arterial Pressure Post nerve block	47 Mmhg Standard Deviation 10.6

PRIMARY outcome

Timeframe: 8 weeks

Assessment of orthostasis, gastrointestinal symptoms were observed

Outcome measures

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Absence of Nerve Block Related Complications	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Peak Oxygen Uptake Baseline	10.5 mL/min/m2 Standard Deviation 2
Peak Oxygen Uptake Post nerve block	9.1 mL/min/m2 Standard Deviation 3

SECONDARY outcome

Timeframe: 4 weeks

Assessed with right heart cath

Outcome measures

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Resting Wedge Pressure Baseline	17.5 mmHg Standard Deviation 9.5
Resting Wedge Pressure Post nerve block	14 mmHg Standard Deviation 1.6

SECONDARY outcome

Timeframe: 4 weeks

Assessed with right heart cath

Outcome measures

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Resting Central Venous Pressure Baseline	9.3 mmHg Standard Deviation 4.9
Resting Central Venous Pressure Post nerve block	5.8 mmHg Standard Deviation 2.4

SECONDARY outcome

Timeframe: 4 weeks

Assessed on right heart catheterization

Outcome measures

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Resting Pulmonary Arterial Pressure Baseline	24 mmHg Standard Deviation 9
Resting Pulmonary Arterial Pressure Post nerve block	20 mmHg Standard Deviation 4

SECONDARY outcome

Timeframe: 4 weeks

The VAS for dyspnea has a range of 0 to 100, where 0 corresponds to the patient's subjective feeling of "I Can Breathe Normally" and a score of 100 corresponds to "I Can't Breathe At All."

Outcome measures

Measure	Splanchnic Nerve Block n=4 Participants Splanchnic nerve block: Percutaneous splanchnic nerve block
Dyspnea - Visual Analog Scale (VAS) Baseline	76 units on a scale Standard Deviation 11
Dyspnea - Visual Analog Scale (VAS) After nerve block	81 units on a scale Standard Deviation 21

Adverse Events

Splanchnic Nerve Block

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Splanchnic Nerve Block n=4 participants at risk Splanchnic nerve block: Percutaneous splanchnic nerve block
Injury, poisoning and procedural complications Pulmonary hemorrhage	25.0% 1/4 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Marat Fudim, MD, MHS

Duke University

Phone: 919-684-1284

Email: marat.fudim@duke.edu

Results disclosure agreements

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