NCT02669407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 6, 2019

Completed
Last Updated

December 6, 2019

Status Verified

May 1, 2018

Enrollment Period

1.7 years

First QC Date

January 22, 2016

Results QC Date

October 29, 2019

Last Update Submit

November 19, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

  • Central Venous Pressure

    Baseline, 90 minutes

  • Pulmonary Arterial Mean Pressure

    baseline, 30 minutes

  • Pulmonary Capillary Wedge Pressure

    baseline, 30 minutes

Secondary Outcomes (11)

  • Cardiac Index

    baseline, 30 minutes

  • Ejection Fraction (LVEF)

    Baseline, 90 minutes

  • Pulmonary Artery Systolic Pressure

    Baseline, 30 minutes

  • Right Ventricular Diameter

    Baseline, 30 mins

  • Left Ventricular Diameter

    Baseline, 30 mins

  • +6 more secondary outcomes

Study Arms (1)

Regional nerve anesthesia

EXPERIMENTAL

Regional nerve anesthesia of splanchnic nerve

Procedure: splanchnic nerve anesthesia with a local anestheticDrug: regional nerve block with a local anesthetic (Lidocaine)

Interventions

splanchnic nerve anesthesia with a local anestheticPROCEDURE

regional nerve block of the splanchnic nerve

Regional nerve anesthesia
regional nerve block with a local anesthetic (Lidocaine)DRUG
Regional nerve anesthesia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 33714749DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Marat Fudim, M.D.
Organization
Duke University
marat.fudim@duke.edu
919-684-8111

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 1, 2016

Study Start

January 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

December 6, 2019

Results First Posted

December 6, 2019

Record last verified: 2018-05

Locations

US(1)