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Heart Failure Re-admission Risk Estimation Using NICaS System With Comparison to Serum BNP Levels

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NICaS system
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring heart failure, BNP, NICaS system, readmition

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent.
  2. HF admitted patient from cardiology and internal medicine departments in our institution.

Exclusion Criteria:

  1. Severe aortic valve regurgitation and/or aortic stenosis.
  2. Aortic aneurysm.
  3. Heart rate above 130 beats/min.
  4. Intra- and extra-cardiac shunts.
  5. Severe peripheral vascular disease.
  6. Severe pitting edema.
  7. Sepsis.
  8. Use of hemodialysis.
  9. Patients under 18 years of age.

Sites / Locations

  • Tel Aviv SoUrasky MC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NICaS system efficacy in HF patients

Arm Description

NICaS system efficacy in HF patients

Outcomes

Primary Outcome Measures

HF readmition
To assess whether the NICaS system can identify high risk HF patient for readmission prior to their discharge compared to serum BNP measurement

Secondary Outcome Measures

Full Information

First Posted
January 8, 2013
Last Updated
July 6, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01765335
Brief Title
Heart Failure Re-admission Risk Estimation Using NICaS System With Comparison to Serum BNP Levels
Official Title
Heart Failure Re-admission Risk Estimation Using NICaS System With Comparison to Serum BNP Levels
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, BNP, NICaS system, readmition

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NICaS system efficacy in HF patients
Arm Type
Experimental
Arm Description
NICaS system efficacy in HF patients
Intervention Type
Device
Intervention Name(s)
NICaS system
Intervention Description
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
Primary Outcome Measure Information:
Title
HF readmition
Description
To assess whether the NICaS system can identify high risk HF patient for readmission prior to their discharge compared to serum BNP measurement
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent. HF admitted patient from cardiology and internal medicine departments in our institution. Exclusion Criteria: Severe aortic valve regurgitation and/or aortic stenosis. Aortic aneurysm. Heart rate above 130 beats/min. Intra- and extra-cardiac shunts. Severe peripheral vascular disease. Severe pitting edema. Sepsis. Use of hemodialysis. Patients under 18 years of age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofer Havakuk, MD
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Tel Aviv SoUrasky MC
City
Tel Aviv
ZIP/Postal Code
64329
Country
Israel

12. IPD Sharing Statement

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Heart Failure Re-admission Risk Estimation Using NICaS System With Comparison to Serum BNP Levels

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