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OpenTrials
Completed

NCT Number: NCT02669407

Splanchnic Nerve Anesthesia in Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

splanchnic nerve anesthesia with a local anesthetic

Procedure

regional nerve block of the splanchnic nerve

regional nerve block with a local anesthetic (Lidocaine)

Drug

Primary outcomes

  1. Central Venous Pressure

    Time frame: Baseline, 90 minutes

  2. Pulmonary Arterial Mean Pressure

    Time frame: baseline, 30 minutes

  3. Pulmonary Capillary Wedge Pressure

    Time frame: baseline, 30 minutes

Secondary outcomes

  1. Cardiac Index

    Time frame: baseline, 30 minutes

  2. Ejection Fraction (LVEF)

    Time frame: Baseline, 90 minutes

  3. Pulmonary Artery Systolic Pressure

    Time frame: Baseline, 30 minutes

  4. Right Ventricular Diameter

    Time frame: Baseline, 30 mins

  5. Left Ventricular Diameter

    Time frame: Baseline, 30 mins

  6. N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level

    Time frame: Baseline; 90 minutes

    NT-proBNP level is elevated in heart failure and reflects its severity. A higher value indicates less stability.

  7. Urine Output Measured in ml Over 3 Hours

    Time frame: Baseline, post-procedure (0-3 hours)

  8. Change in Blood Urea Nitrogen (BUN)

    Time frame: Baseline; 90 minutes

    BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability.

  9. Change in Creatinine Level

    Time frame: Baseline; 90 minutes

    Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.

  10. Dyspnea as Measured on Likert Scale

    Time frame: 15, 30, 45, 60, 75, 90 minutes; 24 hours

    The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change.

  11. Change in Clinical Symptoms, as Measured by 6 Minute Walk Test

    Time frame: Baseline, 90 minutes, 24 hours

    The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Splanchnic Nerve Block for Acute Heart Failure

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2016
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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