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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: splanchnic nerve anesthesia with a local anesthetic Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Regional nerve anesthesia Drug: splanchnic nerve anesthesia with a local anesthetic
regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)




Primary Outcome Measures :
  1. 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.

  2. Mean Pulmonary Arterial Pressure (mPAP) [ Time Frame: baseline, up to 1 hour ]
    Mean pulmonary arterial pressure will be measured before and after nerve block.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Duke
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Manesh Patel Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03453151    
Other Study ID Numbers: Pro00090299
First Posted: March 5, 2018    Key Record Dates
Results First Posted: July 24, 2020
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents