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Heart FailureNCT01765335

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

A study testing NICaS system in people with Heart Failure, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Heart Failure
What is being tested?
NICaS system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteIsrael
Study dates
Jan 2013to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • Sepsis.
  • Use of hemodialysis.
  • Patients under 18 years of age.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Tel Aviv SoUrasky MC

    Tel Aviv, 64329

Other trials in Israel

About this study

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.

Read the 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.

Conditions
Heart Failure
Being tested
NICaS system
Keywords
heart failure, BNP, NICaS system, readmition
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NICaS systemDevice

    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

Study groups in NCT01765335
Study groupRoleWhat they receive
NICaS system efficacy in HF patientsExperimentalNICaS system efficacy in HF patients
Receives: Device: NICaS system

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01765335
Sponsor's protocol ID
NICaS CHF
Status last verified
Jul 2016
First submitted
8 Jan 2013
Last updated
7 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing NICaS system in people with Heart Failure, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HF readmition (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.

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