Heart Failure Re-admission Risk Estimation Using NICaS System With Comparison to Serum BNP Levels
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      HF represents a major burden in the developed world. Mortality and rehospitalization rates
      post-discharge in patients admitted with HF may be as high as 15%-30% within 60-90 days,
      respectively. Given that rehospitalization drives much of the cost associated with HF, there
      has been increased interest in predicting risk of rehospitalization as a means to control
      health care costs. These risk stratification models can serve as important clinical tools by
      helping to identify those patients who are at very high risk may be observed more closely or
      treated more intensively. The most important predictors for the combined endpoint of death or
      rehospitalization were admission serum creatinine concentration, systolic blood
      pressure,admission hemoglobin level, discharge use of ACE-Ior ARBS, and Pulmonary disease.
      Other independent predictors during hospitalization of readmission and mortality included low
      admission Kansas City Cardiomyopathy Questionnaire score, high BNP, hyponatremia,
      tachycardia, hypotension, absence of b-blocker therapy, and history of diabetes and
      arrhythmias. Nevertheless, both models fail to provide the treating physician a simple
      decision making tool for predicting which patient is stable enough to be discharged from the
      hospital without a high risk of readmission. The Non Invasive Cardiac System (NICaS, Israel),
      calculates the cardiac output by measuring impedance cardiography in a tetra-polar mode,
      derived from electrodes placed on both wrists or one wrist and the contra-lateral ankle. This
      simple to operate, non-invasive technique was validated in a few studies to be reliable in
      estimation of CO compared to traditional, invasive techniques in different settings including
      HF patients. A previous study demonstrated that parameters derived from this system showed a
      highly significant correlation to echo estimated EF and serum BNP in chronic HF patients and
      were equally able to predict complications in this population. Aim:To assess whether the
      NICaS system can identify high risk HF patient for readmission prior to their discharge
      compared to serum BNP measurement.
    

Detailed description: 
      Heart failure represents a major burden in the developed world. Mortality and
      rehospitalization rates post-discharge in patients admitted with HF may be as high as 15% and
      30% within 60-90 days, respectively. Given that rehospitalization drives much of the cost
      associated with HF, there has been increased interest in predicting risk of rehospitalization
      as a means to control health care costs. These risk stratification models can serve as
      important clinical tools by helping to identify those patients who are at very high risk may
      be observed more closely or treated more intensively. The most important predictors for the
      combined endpoint of death or rehospitalization were admission serum creatinine
      concentration, systolic blood pressure,admission hemoglobin level, discharge use of ACE-Ior
      ARBS, and Pulmonary disease. Other independent predictors during hospitalization of
      readmission and mortality included low admission Kansas City Cardiomyopathy Questionnaire
      score, high BNP, hyponatremia, tachycardia, hypotension, absence of b-blocker therapy, and
      history of diabetes and arrhythmias. Nevertheless, both models fail to provide the treating
      physician a simple decision making tool for predicting which patient is stable enough to be
      discharged from the hospital without a high risk of readmission. The Non Invasive Cardiac
      System (NICaS, Israel), calculates the cardiac output by measuring impedance cardiography in
      a tetra-polar mode, derived from electrodes placed on both wrists or one wrist and the
      contra-lateral ankle. This simple to operate, non-invasive technique was validated in a few
      studies to be reliable in estimation of CO compared to traditional, invasive techniques in
      different settings including HF patients. A previous study demonstrated that parameters
      derived from this system showed a highly significant correlation to echo estimated EF and
      serum BNP in chronic HF patients and were equally able to predict complications in this
      population. Aim:To assess whether the NICaS system can identify high risk HF patient for
      readmission prior to their discharge compared to serum BNP measurement.Methods and
      population:Known HF patients, admitted due to HF exacerbation, will be tested with NICaS
      system in concordance with serum BNP measurement prior to their discharge from the hospital.
      The decision for discharge will be made on clinical ground by the treating physician alone.
      The patients will be tested by NICaS system in the following manner-patches will be attached
      to both patient's wrists, or one wrist and contra-lateral ankle for a period of approximately
      30 seconds. During that time the patient will be seated or supine.3cc of blood will be drawn
      from peripheral vein for BNP level measurement.NICaS parameters and serum BNP levels will be
      processed in an excel sheet. The patients will be followed by a telephone questionnaire after
      3 months from discharge in order to document events of readmission or death.
    

Intervention name(s): NICaS system
Intervention type(s): Device
Intervention description(s): NICaS parameters (cardiac output and total peripheral resistance) and serum BNP levels will be processed in an excel sheet including study reference number to keep confidentiality
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: heart failure, BNP, NICaS system, readmition