Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)

June 21, 2023 updated by: Duke University
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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Activation of splanchnic nerves results in vasoconstriction and reduces splanchnic capacitance, therefore recruiting blood volume into the central circulation. In heart failure, a reduced splanchnic vascular capacitance could be the mechanism underlying symptoms of exercise intolerance and could predispose to rapid decompensation with external fluid intake or retention. A compromised vascular reservoir is likely unable to buffer shifts of fluid and actively contributes to the acute or chronic expulsion of fluid from the splanchnic vascular compartment to the central thoracic compartment. The redistribution of blood volume into the central circulation may lead to a sudden rise in pulmonary and left-sided cardiac pressures in HF. This makes the splanchnic vascular compartment an attractive target in heart failure. Our preliminary proof-of-concept work in patients with acute decompensated and chronic heart failure showed promise for the concept of splanchnic nerve modulation in heart failure. In a series of two small first-in-human studies for acute decompensated heart failure (N=13) (NCT02669407) and chronic heart failure (N=17) (NCT03453151), we found that a splanchnic nerve block (SNB) with lidocaine (90 min duration of action) and ropivacaine (24 hours duration of action) acutely reduced resting and exercise-induced intra-cardiac filling pressures, associated with improved patient symptoms and functional capacity.

The present study will be a prospective open-label pilot study to help establish feasibility, safety and enable dose finding for botulinumtoxin. Following a baseline invasive (right heart catheterization) cardiopulmonary exercise testing (CPX) patients will undergo unilateral celiac plexus block, followed by repeat hemodynamic testing. Functional testing at baseline and follow up will be supplemented by measures of blood volume and autonomic tone.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Splanchnic nerve block
Percutaneous splanchnic nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Exercise Wedge Pressure
Time Frame: 4 weeks
Measured with cardiopulmonary exercise testing
4 weeks
Peak Pulmonary Arterial Pressure
Time Frame: 4 weeks
Measured on exercise cardiopulmonary stress test
4 weeks
Absence of Nerve Block Related Complications
Time Frame: 8 weeks
Assessment of orthostasis, gastrointestinal symptoms were observed
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Oxygen Uptake
Time Frame: 4 weeks
4 weeks
Resting Wedge Pressure
Time Frame: 4 weeks
Assessed with right heart cath
4 weeks
Resting Central Venous Pressure
Time Frame: 4 weeks
Assessed with right heart cath
4 weeks
Resting Pulmonary Arterial Pressure
Time Frame: 4 weeks
Assessed on right heart catheterization
4 weeks
Dyspnea - Visual Analog Scale (VAS)
Time Frame: 4 weeks
The VAS for dyspnea has a range of 0 to 100, where 0 corresponds to the patient's subjective feeling of "I Can Breathe Normally" and a score of 100 corresponds to "I Can't Breathe At All."
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Marat Fudim, MD, MHS, Duke Universtiy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Actual)

June 16, 2021

Study Completion (Actual)

June 16, 2021

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00103788

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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