Abdominal Nerve Blockade in Chronic Heart Failure.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03453151|
Recruitment Status : Completed
First Posted : March 5, 2018
Results First Posted : July 24, 2020
Last Update Posted : July 24, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: splanchnic nerve anesthesia with a local anesthetic||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF|
|Actual Study Start Date :||May 1, 2018|
|Actual Primary Completion Date :||June 27, 2019|
|Actual Study Completion Date :||December 27, 2019|
|Experimental: Regional nerve anesthesia||
Drug: splanchnic nerve anesthesia with a local anesthetic
regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)
- Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) [ Time Frame: baseline, up to 1 hour ]Peak VO2 will be measured before and after nerve block.
- Mean Pulmonary Arterial Pressure (mPAP) [ Time Frame: baseline, up to 1 hour ]Mean pulmonary arterial pressure will be measured before and after nerve block.
- Pulmonary Capillary Wedge Pressure (PCWP) [ Time Frame: baseline, up to 1 hour ]Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.
- Cardiac Index (CI) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453151
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Manesh Patel||Duke University|