Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04548024 |
Other study ID # |
PPGCHF001 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 10, 2020 |
Est. completion date |
December 10, 2021 |
Study information
Verified date |
December 2021 |
Source |
Biobeat Technologies Ltd. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Our aim is to assess whether changes in CO, CI and SVR as measured using the Biobeat
wearable, wireless, non-invasive device during IV diuretic administration in an outpatient
setting among CHF patients correlate with short-term clinical change measured using symptoms
questionnaires, change in weight and urine output. We will also assess the correlation
between baseline values of those parameters and long-term clinical outcomes, measured by HF
hospitalizations and the change in disease perception and quality of life reported in
questionnaires.
Description:
Heart failure (HF) is a common clinical syndrome resulting from structural and/or functional
cardiac abnormality. It affects 2.2% of American adults and over 12% of Americans ≥80 years
of age, and its total cost in the US was estimated at $30.7 billion in 2012. As prevalence
and overall cost are expected to considerably rise in the coming years, HF continues to
constitute a major burden to global health.
HF is characterized with a progressive course of disease with high hospital readmission
rates, which account for a major portion of the economic burden. Improving the management of
congestion has been a crucial component in the efforts to reduce hospitalizations. Congestion
is a cardinal manifestation of HF, presenting with dyspnea, orthopnea, and edema due to
volume overload. Diuretics remain a cornerstone in the management of congestion; however,
there are no clear guidelines on how to adjust their administration. Guidelines recommend
monitoring of daily weight changes, but efficacy is debatable. Thus, there is a pressing need
to find reliable markers to promptly recognize deteriorations and help tailor diuretic
treatment to prevent them. To date, European Society of Cardiology (ESC) guidelines recommend
two invasive monitoring approaches to guide management, one based on invasive wireless
pulmonary artery pressure monitoring and the other on utilizing data from Implantable
Cardioverter Defibrillators (ICDs). Hemodynamic monitoring using invasive right heart
catheterization has not shown benefit in management of HF decompensations, and nowadays is
reserved only for specific clinical scenarios. In the field of non-invasive monitoring,
research efforts have focused on analyzing lung impedance, ECG , and heart sounds with some
promising results; a recent study utilized machine learning to generate a personalized alert
system, but with a limited number of parameters monitored. Nevertheless, their algorithm's
success in predicting hospitalizations reflects the importance of recognizing the
heterogeneity of HF and the advantages of an individualized approach.
In this study, we will examine the use of a non-invasive, user-friendly device (BB-613WP,
Biobeat Technologies LTD, Petah Tikva, Israel), in advanced HF patients receiving IV diuresis
in a hospital outpatient clinic. The device can derive measurements of several parameters,
including cardiac output (CO), cardiac index (CI), blood pressure (BP) and systemic vascular
resistance (SVR) using photoplethysmography (PPG) technology, and has been tested in several
clinical trials. We wish to assess if CO, CI and SVR can be utilized as markers for HF
clinical course, so they can ideally be used to intervene and modify treatment prior to a
deterioration.
The literature describing the effects of diuresis on CO and SVR is rather limited and
archaic. Most studies found a reduction in CO and a rise in SVR after diuresis, but some
describe the opposite, and some describe a response changing over time. This can be explained
when considering that the pathophysiology underlying the effects of volume status on cardiac
performance in HF is complex. The classically described Frank-Starling principle states that
contractility peaks at a muscle length that allows for optimal overlap of actin and myosin
filaments and maximal calcium ions sensitivity. Up to a certain point, the longer the muscle
is (represented as larger EDV, end diastolic volume), the higher the force of contraction.
But beyond that length, the contractile force decreases. Since different patients are
characterized with different levels of cardiac filling, volume reduction induced by diuresis
may have a different impact on CO, depending on the position on the Frank Starling curve. For
instance, impaired ventricular filling in HF with preserved ejection fraction can reduce
systolic function, due to less effective contraction in low EDV. Similarly, SVR, which is
inversely proportional to CO, is likely to be affected differently. Our primary objective is
to assess whether the changes in CO, CI and SVR during IV diuretic administration correlate
with short-term clinical change measured using symptoms questionnaires, change in weight and
urine output. Our secondary objective is to assess the correlation between baseline values of
those parameters and long-term clinical outcomes, measured by HF hospitalizations and the
change in disease perception and quality of life reported in questionnaires.