Heart Failure Clinical Trial

Splanchnic Nerve Anesthesia in Heart Failure

Summary

Patients admitted for acute 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. Patients will remain in the catheterization lab for the duration of anesthetic block and will be continuously hemodynamically monitored.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of heart failure (HF)
Prior admissions for decompensated HF
Symptomatic with dyspnea with clinical, radiographic or echocardiographic signs of fluid overload
On a stable HF drug regimen prior to admission
Anticipated hospital stay of at least 2 nights following catheterization procedure

Exclusion Criteria:

Ongoing treatment with oral anticoagulation other than aspirin
Immunosuppressive medications for solid organ transplant
Acute MI (STEMI or NSTEMI) within 7 days
Evidence of cardiogenic shock within 48 hours
Systolic blood pressure < 90 mmHg or >180 mmHg
Restrictive or constrictive cardiomyopathy
Chronic kidney disease stage 3 or higher due to primary renal pathology
Pregnancy

Study is for people with:

Heart Failure

Estimated Enrollment:

14

Study ID:

NCT02669407

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

14

Study ID:

NCT02669407

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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