Abdominal Nerve Blockade in Chronic Heart Failure.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regional nerve anesthesia

Group Type EXPERIMENTAL

splanchnic nerve anesthesia with a local anesthetic

Intervention Type DRUG

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

Interventions

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splanchnic nerve anesthesia with a local anesthetic

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No