NCT04575428

Brief Summary

Splanchnic vasoconstriction may contribute to decompensation of chronic heart failure (HF) via volume redistribution from the splanchnic vascular bed to the central compartment. This is a sympathetically mediated reflex and can be interrupted through a splanchnic nerve block (SNB). We hypothesize that interruption of the efferent/afferent innervation of the splanchnic vasculature will decrease cardiac congestion in patients presenting with HF. Based on preliminary safety and efficacy data in acute and chronic heart failure patients with temporary (\<24 h) SNB. Now we will apply a prolonged SNB in chronic heart failure patients using a long acting agent. We will test the effects of SNB on long term exercise capacitance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

February 5, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 15, 2023

Completed
Last Updated

June 27, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

August 20, 2020

Results QC Date

May 19, 2023

Last Update Submit

June 21, 2023

Conditions

Chronic Heart Failure

Keywords

heart failure, exercise, splanchnic nerve block

Outcome Measures

Primary Outcomes (3)

  • Peak Exercise Wedge Pressure

    Measured with cardiopulmonary exercise testing

    4 weeks

  • Peak Pulmonary Arterial Pressure

    Measured on exercise cardiopulmonary stress test

    4 weeks

  • Absence of Nerve Block Related Complications

    Assessment of orthostasis, gastrointestinal symptoms were observed

    8 weeks

Secondary Outcomes (5)

  • Peak Oxygen Uptake

    4 weeks

  • Resting Wedge Pressure

    4 weeks

  • Resting Central Venous Pressure

    4 weeks

  • Resting Pulmonary Arterial Pressure

    4 weeks

  • Dyspnea - Visual Analog Scale (VAS)

    4 weeks

Study Arms (1)

Splanchnic nerve block

EXPERIMENTAL
Drug: Splanchnic nerve block

Interventions

Splanchnic nerve blockDRUG

Percutaneous splanchnic nerve block

Splanchnic nerve block

Eligibility Criteria

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

You may qualify if:

  • Followed at DUMC for known or suspected diagnosis of HF (NYHA stage 2-4, Class C-D), including patients on inotropic medication
  • Systolic blood pressure (SBP) \> 100 mmHg
  • History of HF hospitalization or ER visit or iv diuretic use in last 12 months.
  • Patients will be included regardless of left ventricular ejection fraction.

You may not qualify if:

  • Anticoagulation at the time the procedure or in case of recent warfarin use an INR \>1.4. Anticoagulation includes: warfarin, or novel oral anticoagulants like dabigatran, rivaroxaban, apixaban, endoxaban or full dose intravenous heparin products or bivalirudin and fondaparinux). Antiplatelet agents besides aspirin such as ticagrelor, prasugrel, Plavix are also considered to be a contraindication if used at time point of procedure.
  • Immunosuppressive medications for solid organ transplant
  • Acute MI (STEMI or Type I NSTEMI) within 7 days?
  • Evidence of progressive cardiogenic shock within 48 hours
  • Restrictive cardiomyopathy
  • Constrictive pericarditis
  • Pericardial effusion with evidence of tamponade
  • Severe valvular stenosis requiring intervention
  • Known history of an increased bleeding risk
  • Thrombocytopenia (\< 50,000)
  • End-stage renal disease CKD stage 5 due to primary renal pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Results Point of Contact

Title
Marat Fudim, MD, MHS
Organization
Duke University
marat.fudim@duke.edu
919-684-1284

Study Officials

  • Marat Fudim, MD, MHS

    Duke Universtiy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

October 5, 2020

Study Start

February 5, 2020

Primary Completion

June 16, 2021

Study Completion

June 16, 2021

Last Updated

June 27, 2023

Results First Posted

June 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)