- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04575428
Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Marat Fudim, MD, MHS
- Phone Number: 9196848111
- Email: marat.fudim@duke.edu
Study Contact Backup
- Name: Manesh Patel, MD
- Phone Number: 9196688917
- Email: manesh.patel@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Marat Fudim, MD, MHS, Duke Universtiy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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