Last updated on August 2018

Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart Failure Acute
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Left Ventricular Ejection fraction < 40%, measured in the last year
  2. At least two of the following:
    • Pulmonary Capillary Wedge Pressure > 18 mmHg
    • Pulmonary congestion on Chest X-ray
    • Jugular vein distension
    • Pulmonary rales
    • Edema
    • Dyspnea at rest
    • Two (2) emergency room visits or hospital admissions in the past three (3) months, or three (3) emergency room visits or admissions in the past six (6) months requiring intravenous diuretics, ultrafiltration or in-hospital inotropic therapy.
  3. With or without evidence of low perfusion

Exclusion Criteria:

  1. Systolic Blood Pressure < 90 mmHg or > 160 mmHg
  2. Catecholamine or inotropic therapy within the previous 48 hours
  3. Levosimendan within the previous 72 hours
  4. Chronic outpatient catecholamine or inotropic therapy
  5. Presence of implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device
  6. Presence of or prior vagal nerve stimulator
  7. Coronary artery bypass graft surgery, percutaneous coronary intervention, acute myocardial infarction, or valve replacement within prior 1 month
  8. Second or third degree heart block
  9. History of atrial or ventricular arrhythmias
  10. History of mitral or aortic valve stenosis or regurgitation
  11. Hypertrophic obstructive or infiltrative cardiomyopathy
  12. Prior vagotomy
  13. Prior heart transplant
  14. Narrow angle glaucoma
  15. Renal failure - either on dialysis or serum creatinine > 2.0 mg/dl
  16. Hepatic failure - bilirubin, serum glutamic oxaloacetic transaminase, or serum glutamic pyruvic transaminase > four times upper limit of normal
  17. Life expectancy < 12 months per physician judgment
  18. Women who are pregnant
  19. Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products
  20. Subjects unwilling or unable to provide consent

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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