Abdominal Nerve Blockade in Chronic Heart Failure.
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|ClinicalTrials.gov Identifier: NCT03453151|
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : May 17, 2018
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)|
|Estimated Enrollment :||20 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|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
|Experimental: Regional nerve anesthesia||
Drug: splanchnic nerve anesthesia with a local anesthetic
regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)
- Change in exercise capacity [ Time Frame: 1 h ]Improvement in exercise capacity will be measured at 20 Watts steady state and peak exercise. Exercise capacity is measured in peak VO2
- Change in pulmonary arterial mean pressure [ Time Frame: 1 h ]Reduction in pulmonary arterial mean pressure will be measured before and after nerve block
- Change in pulmonary wedge pressure [ Time Frame: 1 h ]Improvement in wedge will be measured at 20 Watts steady state and peak exercise.
- Change in cardiac output [ Time Frame: 1 hour ]Improvement in wedge will be measured at 20 Watts steady state and peak exercise.
- Improvement in urine output [ Time Frame: 2 h ]Urine output will be measured in the 2 hours before the nerve block and in the 2 hours afterwards
- Improvement in renal biomarkers [ Time Frame: 2 h ]We will measure BUN and creatinine
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
|Contact: Manesh Patel||(919) firstname.lastname@example.org|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Manesh Patel 919-681-5816 email@example.com|
|Principal Investigator:||Manesh Patel||Duke University|