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

NCT01765335 | Completed

• 1 other identifier: NICaS CHF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure, BNP, NICaS system, readmition

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Study Arms (1)

NICaS system efficacy in HF patients

EXPERIMENTAL

NICaS system efficacy in HF patients

Device: NICaS system

Interventions

NICaS system DEVICE

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

NICaS system efficacy in HF patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv SoUrasky MC

Tel Aviv, 64329, Israel

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ofer Havakuk, MD

  Tel Aviv Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of R&D

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 10, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

IL (1)