Ignite Creation Date:
2024-05-06 @ 2:48 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02126254
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2014-04-22
Brief Title:
Optimization of the Treatment of Acute HF by a Non Invasive Cardiac System-a Randomized Control Trial
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Optimization of the Treatment of Acute Heart Failure by a Non Invasive Cardiac System-Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HFNICAS
Brief Summary:
The aim of this trial is to compare the efficacy of NICaS-directed treatment strategy to the common treatment strategy based on clinical judgment on morbidity and mortality in patients with decompensated congestive heart failure and accordingly to assess whether the NICaS system can optimize and individualize the treatment of decompensated heart failure patients A prospective randomized controlled trial in which Known HF patients with reduced EF 40 admitted due to decompensated HF will be randomly assigned in a 11 ratio to either 1 Control group that will be treated in the cardiology and internal medicine departments according to the guidelines for the management of Heart Failure 2 Hemodynamic group patients will be examined in the cardiology and internal medicine departments and treated according to the NICaS system in addition to current guidelines Patients in this group will be tested within 12 hours from hospitalization and thereafter on an everyday basis until discharge For all patients randomized therapy will be tailored to the ultimate goal of discharge on an oral medical regimen to provide better relief of CHF symptoms to reduce filling pressures and to maintain adequate perfusion These goals are the same for both groups but in the control group therapy will be adjusted according to clinical assessment alone while in the NICaS-directed group actual measurement of hemodynamics will be used to supplement clinical assessment
Detailed Description:
Heart failure is a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood Although survival has improved the absolute mortality rates for HF remain approximately 50 within 5 years of diagnosis In the ARIC study the 30-day 1-year and 5-year mortallity rates after hospitalization for HF were 104 22 and 423 respectively HF represents a major burden in the developed world In the United States HF is the primary diagnosis for more than 1 million hospitalized patients annually A significant number of patients with acute decompensated heart failure have baseline renal insufficiency Yet perhaps more important is the change of renal function during hospitalization Gottlieb et al have shown that even a small increase in serum creatinine eg 01 mgdl will worsen the outcome of the patients It is also noteworthy that a significant rise in serum Cr generally may occur in the first 3 d of the admission to the hospital The mortality rate in ADHERE registry is 4 for all the patients however the mortality of patients with significant renal insufficiency ie Cr 3 mgdl is 94 and the length of hospital stay is also lengthened as compared with those who do not have renal insufficiency In another study of 1681 patients admitted for ADHF Krumholz et al found worsening renal function during hospitalization in 28 of patients In-hospital mortality was more than double in those with versus without worsening renal function 7 versus 3 This significant difference remained at 30 d 10 versus 6 and 6 mo 25 versus 19 The CHARM investigators also studied predictors of outcome in all three component trials in 2680 patients for an average of 34 mo They found that every 10 mlmin decrease in eGFR increased the adjusted HR of cardiovascular death or readmission to the hospital by 10 110 CI 107 to 113 P 0001 Therefore even small changes in Cr have an important impact on in-patient mortality as well as postdischarge mortality
Patients hospitalized for HF are at high risk for all-cause rehospitalization with a 1-month readmission rate of 25 4 In 2013 physician office visits for HF cost 18 billion The total cost of HF care in the United States exceeds 30 billion annually with over half of these costs spent on hospitalizations 3 Presently HF is the leading cause of hospitalization among patients 65 years of age the largest percentage of expenditures related to HF are directly attributable to hospital costs Moreover in addition to costs hospitalization for acutely decompensated HF represents a sentinel prognostic event in the course of many patients with HF with a high risk for recurrent hospitalization 50 at 6 months Median length of in-hospital stay in the United States is approximately 4 days whereas lengths of stay in Europe are generally markedly longer with a median of 9 days as reported in the EuroHeart Failure Survey II Although systemic and pulmonary congestion is the main reason for hospitalization in most patients many do not have a decrease in body weight during their hospital stay and are discharged with signs and symptoms of HF Given that re-hospitalization drives much of the cost associated with HF there has been increased interest in predicting risk of re-hospitalization as a means to control health care costs and reduce future risk These risk stratification models can serve as important clinical tools by helping to identify those patients at both ends of the spectrum of risk patients who are at very high risk may be observed more closely or treated more intensively whereas patients at low risk may need less rigorous follow-up and monitoring In the cohort from the OPTIMIZE-HF study with 60- to 90-day follow-up data the most important predictors for the combined endpoint of death or re-hospitalization were admission serum creatinine concentration systolic blood pressure admission hemoglobin level discharge use of ACE inhibitor or ARB and pulmonary disease In the EVEREST trial composed of patients admitted with worsening HF and reduced ejection fraction independent predictors during hospitalization of readmission and mortality included low admission Kansas City Cardiomyopathy Questionnaire score high BNP hyponatremia tachycardia hypotension absence of beta 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 On this regard high levels of BNP were found to be a reliable prognostic marker for HF patients readmission after discharge Hospitalized patients with HF can be classified into important subgroups These include patients with acute coronary ischemia accelerated hypertension and acutely decompensated HF shock and acutely worsening right HF Each of these various categories of HF has specific etiologic factors leading to decompensation presentation management and outcomes Noninvasive modalities can be used to classify the patient with hospitalized HF The history and physical examination allows estimation of a patients hemodynamic status that is the degree of congestion dry versus wet as well as the adequacy of their peripheral perfusion warm versus cold There have been limited previous randomized trials of therapy tailored during continuous hemodynamic monitoring in heart failure Use of an indwelling pulmonary artery catheters to adjust therapy in advanced heart failure was first described by Kovick et al and subsequently by Pierpont for vasodilator therapy in decompensated heart failure with high systemic vascular resistance There have been 11 additional randomized trials of PACs in critical care A meta-analysis of these trials including ESCAPE showed that PAC was neutral in its effect on mortality and rehospitalization These trials support the safety of PACs and the overall neutral effect while highlighting the challenge of assessing a diagnostic tool without a consistent strategy of response with effective therapies These results might be explained by the balance effect of improved treatment by tailored medicine that was counteracted by the invasive nature of PAC
The Non-Invasive Cardiac System NICaS NI Medical Hod-Hasharon Israel calculates the cardiac output CO by measuring whole body bio impedance 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 several 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 echocardiogram estimated ejection fraction and serum BNP in chronic HF patients and were equally able to predict complications in this population
Patients hospitalized for HF are at high risk for all-cause rehospitalization with a 1-month readmission rate of 25 4 In 2013 physician office visits for HF cost 18 billion The total cost of HF care in the United States exceeds 30 billion annually with over half of these costs spent on hospitalizations 3 Presently HF is the leading cause of hospitalization among patients 65 years of age the largest percentage of expenditures related to HF are directly attributable to hospital costs Moreover in addition to costs hospitalization for acutely decompensated HF represents a sentinel prognostic event in the course of many patients with HF with a high risk for recurrent hospitalization 50 at 6 months Median length of in-hospital stay in the United States is approximately 4 days whereas lengths of stay in Europe are generally markedly longer with a median of 9 days as reported in the EuroHeart Failure Survey II Although systemic and pulmonary congestion is the main reason for hospitalization in most patients many do not have a decrease in body weight during their hospital stay and are discharged with signs and symptoms of HF Given that re-hospitalization drives much of the cost associated with HF there has been increased interest in predicting risk of re-hospitalization as a means to control health care costs and reduce future risk These risk stratification models can serve as important clinical tools by helping to identify those patients at both ends of the spectrum of risk patients who are at very high risk may be observed more closely or treated more intensively whereas patients at low risk may need less rigorous follow-up and monitoring In the cohort from the OPTIMIZE-HF study with 60- to 90-day follow-up data the most important predictors for the combined endpoint of death or re-hospitalization were admission serum creatinine concentration systolic blood pressure admission hemoglobin level discharge use of ACE inhibitor or ARB and pulmonary disease In the EVEREST trial composed of patients admitted with worsening HF and reduced ejection fraction independent predictors during hospitalization of readmission and mortality included low admission Kansas City Cardiomyopathy Questionnaire score high BNP hyponatremia tachycardia hypotension absence of beta 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 On this regard high levels of BNP were found to be a reliable prognostic marker for HF patients readmission after discharge Hospitalized patients with HF can be classified into important subgroups These include patients with acute coronary ischemia accelerated hypertension and acutely decompensated HF shock and acutely worsening right HF Each of these various categories of HF has specific etiologic factors leading to decompensation presentation management and outcomes Noninvasive modalities can be used to classify the patient with hospitalized HF The history and physical examination allows estimation of a patients hemodynamic status that is the degree of congestion dry versus wet as well as the adequacy of their peripheral perfusion warm versus cold There have been limited previous randomized trials of therapy tailored during continuous hemodynamic monitoring in heart failure Use of an indwelling pulmonary artery catheters to adjust therapy in advanced heart failure was first described by Kovick et al and subsequently by Pierpont for vasodilator therapy in decompensated heart failure with high systemic vascular resistance There have been 11 additional randomized trials of PACs in critical care A meta-analysis of these trials including ESCAPE showed that PAC was neutral in its effect on mortality and rehospitalization These trials support the safety of PACs and the overall neutral effect while highlighting the challenge of assessing a diagnostic tool without a consistent strategy of response with effective therapies These results might be explained by the balance effect of improved treatment by tailored medicine that was counteracted by the invasive nature of PAC
The Non-Invasive Cardiac System NICaS NI Medical Hod-Hasharon Israel calculates the cardiac output CO by measuring whole body bio impedance 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 several 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 echocardiogram estimated ejection fraction and serum BNP in chronic HF patients and were equally able to predict complications in this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None