NCT03453151

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1 heart-failure

Timeline
Completed

Started May 2018

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

February 20, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

February 20, 2018

Results QC Date

June 15, 2020

Last Update Submit

July 23, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

  • Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)

    Peak VO2 will be measured before and after nerve block.

    baseline, up to 1 hour

  • Mean Pulmonary Arterial Pressure (mPAP)

    Mean pulmonary arterial pressure will be measured before and after nerve block.

    baseline, up to 1 hour

  • Pulmonary Capillary Wedge Pressure (PCWP)

    Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.

    baseline, up to 1 hour

Secondary Outcomes (3)

  • Cardiac Index (CI)

    baseline, up to 1 hour

  • Urine Output

    2 hours pre-SNB, 2 hours post-SNB

  • Renal Biomarker Levels

    2 hours pre-SNB, 2 hours post-SNB

Study Arms (1)

Regional nerve anesthesia

EXPERIMENTAL
Drug: splanchnic nerve anesthesia with a local anesthetic

Interventions

splanchnic nerve anesthesia with a local anestheticDRUG

regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)

Regional nerve anesthesia

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

  • Kittipibul V, Ganesh A, Coburn A, Coyne BJ, Gray JM, Molinger J, Ray N, Podgoreanu M, McCartney SL, Mamoun N, Fitzhugh RC, Lurz P, Green CL, Hernandez AF, Patel MR, Fudim M. Splanchnic Nerve Modulation Effects on Surrogate Measures of Venous Capacitance. J Am Heart Assoc. 2023 Jul 18;12(14):e028780. doi: 10.1161/JAHA.122.028780. Epub 2023 Jul 14.

    PMID: 37449573DERIVED

  • 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

  • Fudim M, Boortz-Marx RL, Ganesh A, DeVore AD, Patel CB, Rogers JG, Coburn A, Johnson I, Paul A, Coyne BJ, Rao SV, Gutierrez JA, Kiefer TL, Kong DF, Green CL, Jones WS, Felker GM, Hernandez AF, Patel MR. Splanchnic Nerve Block for Chronic Heart Failure. JACC Heart Fail. 2020 Sep;8(9):742-752. doi: 10.1016/j.jchf.2020.04.010. Epub 2020 Jun 10.

    PMID: 32535123DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Marat Fudim
Organization
Duke University
marat.fudim@duke.edu
(919) 681-5816

Study Officials

  • Manesh Patel

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 5, 2018

Study Start

May 1, 2018

Primary Completion

June 27, 2019

Study Completion

December 27, 2019

Last Updated

July 24, 2020

Results First Posted

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)