Abdominal Nerve Blockade in Chronic Heart Failure.

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Drug: splanchnic nerve anesthesia with a local anesthetic

• Registration Number: NCT03453151
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-05
• Study Start: 2018-05-01
• Primary Completion: 2019-06-27
• Study Completion: 2019-12-27
• Results First Submitted: 2020-06-15
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Results First Posted: 2020-07-24
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Diagnosis of heart failure (HF)
• Symptomatic with dyspnea
• On a stable HF drug regimen

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regional nerve anesthesia	splanchnic nerve anesthesia with a local anesthetic	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke; 🇺🇸 Durham, North Carolina, United States