Clinical trial NCT02669407: Splanchnic Nerve Anesthesia in Heart Failure
Official title: Splanchnic Nerve Block for Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Central Venous Pressure
timeFrame: Baseline, 90 minutes
measure: Pulmonary Arterial Mean Pressure
timeFrame: baseline, 30 minutes
measure: Pulmonary Capillary Wedge Pressure
timeFrame: baseline, 30 minutes
Secondary outcomes:
measure: Cardiac Index
timeFrame: baseline, 30 minutes
measure: Ejection Fraction (LVEF)
timeFrame: Baseline, 90 minutes
measure: Pulmonary Artery Systolic Pressure
timeFrame: Baseline, 30 minutes
measure: Right Ventricular Diameter
timeFrame: Baseline, 30 mins
measure: Left Ventricular Diameter
timeFrame: Baseline, 30 mins
measure: N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level
timeFrame: Baseline; 90 minutes
measure: Urine Output Measured in ml Over 3 Hours
timeFrame: Baseline, post-procedure (0-3 hours)
measure: Change in Blood Urea Nitrogen (BUN)
timeFrame: Baseline; 90 minutes
measure: Change in Creatinine Level
timeFrame: Baseline; 90 minutes
measure: Dyspnea as Measured on Likert Scale
timeFrame: 15, 30, 45, 60, 75, 90 minutes; 24 hours
measure: Change in Clinical Symptoms, as Measured by 6 Minute Walk Test
timeFrame: Baseline, 90 minutes, 24 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke
state: North Carolina
Study officials:
References:
citation: Fudim M, Patel MR, Boortz-Marx R, Borlaug BA, DeVore AD, Ganesh A, Green CL, Lopes RD, Mentz RJ, Patel CB, Rogers JG, Felker GM, Hernandez AF, Sunagawa K, Burkhoff D. Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure. JACC Heart Fail. 2021 Apr;9(4):293-300. doi: 10.1016/j.jchf.2020.12.006. Epub 2021 Mar 10.