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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
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


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. 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

  2. Change in pulmonary arterial mean pressure [ Time Frame: 1 h ]
    Reduction in pulmonary arterial mean pressure will be measured before and after nerve block

  3. Change in pulmonary wedge pressure [ Time Frame: 1 h ]
    Improvement in wedge will be measured at 20 Watts steady state and peak exercise.


Secondary Outcome Measures :
  1. Change in cardiac output [ Time Frame: 1 hour ]
    Improvement in wedge will be measured at 20 Watts steady state and peak exercise.

  2. 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

  3. Improvement in renal biomarkers [ Time Frame: 2 h ]
    We will measure BUN and creatinine



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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


Contacts
Contact: Manesh Patel (919) 681-5816 manesh.patel@duke.edu

Locations
United States, North Carolina
Duke Recruiting
Durham, North Carolina, United States, 27710
Contact: Manesh Patel    919-681-5816    manesh.patel@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Manesh Patel Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03453151     History of Changes
Other Study ID Numbers: Pro00090299
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents