Clinical trial NCT04455828: Wearable Remote Monitoring of Heart Rate and Respiratory Rate for Heart Failure
Official title: Wearable Remote Monitoring of Heart Rate and Respiratory Rate for Heart Failure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Keywords: Heart Failure
Remote Monitoring
WHOOP strap 3.0
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, 18 and older, admitted to the hospital with a primary diagnosis of acute heart failure or any stable patient who presents for routine outpatient care, but has a diagnosis of Heart Failure, and is NYHA class II-IV at time of enrollment.

Brief summary: The primary objective of this study is to study in heart failure (HF) patients to better assess HF disease state, which can aid in management and improve outcomes. Primary aims of the study include: (1) Measure HR and RR at rest and during daily activity using the WHOOP device. (2) Correlate HR and RR response to activity to New York Heart Association (NYHA) class and 90-day HF hospitalization rate. (3) Identify additional predictors of NYHA class and HF hospitalization rate for algorithm development to use the WHOOP device as a clinical tool for HF management.

Detailed description: Heart Failure (HF) is a challenging condition to manage, with hospital readmission for HF exacerbation having negative impacts on patient outcomes and financial burden to both patient and health system \[Lloyd-Jones, 2010; Yancy, 2017; Ross, 2009; Chaudhry, 2007\]. An intuitive need for more sensitive predictors of HF exacerbations has led researchers to explore remote monitoring as a possible answer. Consumer-owned sensors have become more accurate in their recording of vital signs, and thus could hold potential for remote monitoring \[Dickinson, 2018\]. The combined measure of heart rate (HR) and respiratory rate (RR) has been shown to predict New York Heart Association (NYHA) HF class, an indicator of severity of heart disease, in implantable cardiac devices with multi-sensor monitoring capabilities \[Auricchio, 2014; Prasun, 2019; Boehmer, 2015; Boehmer, 2017\]. Heart rate variability (HRV), a measure of sympathetic autonomic function, has also shown potential in prediction of adverse cardiac events \[Al-Zaiti, 2019; Shaffer, 2017; Bullinga, 2005; Tsuji, 1996\].

The WHOOP device, a wearable strap similar to a Fitbit, allows for real-time HR monitoring and can determine RR using respiratory sinus arrhythmia \[www.whoop.com/experience; Berryhill, 2020\]. It is one of the few devices on the market that can accurately track heart rate as well as respiratory rate in real-time (during activity) and is equipped with a multidirectional accelerometer for activity tracking. The WHOOP device was recently externally validated against polysomnography and continuous electroencephalogram (EEG) for sleep tracking, and continuous electrocardiogram (ECG) for HR and HRV (with less than 5% error) \[Berryhill, 2020\]. HRV, which represents the balance of the sympathetic and parasympathetic nervous systems, is a known predictor of cardiac events. It is especially useful in HF, which is a chronically elevated catecholamine state leading to depressed HRV and is tied to NYHA HF class, an indicator of severity of disease \[Bullinga, 2005; Tsuji, 1996\].

Data so far regarding the efficacy of remote physiologic monitoring using cardiac implantable electronic devices (CIEDs), although promising in theory, has not yet proved sensitive in the detection of HF exacerbation. The aim of the CLEPSYDRA study was to use data extracted from implanted cardiac resynchronization therapy with defibrillation (CRT-D) devices in HF patients to predict heart failure events; although the main variables used in the novel algorithm, minute ventilation and patient activity, would intuitively seem to be predictors of poor outcome/HF exacerbation, the sensitivity of the algorithm to predict an event was only 34% \[6\]. It would appear that this combination of variables is not sufficient to predict adverse HF events. However, the HOME-CARE (HOME Monitoring in CArdiac REsynchronization Therapy) study showed more promising results, as their enhanced predictor, utilizing seven diagnostic variables from implanted CRT-Ds, boasted a sensitivity of 65.4% \[Sack, 2011\]. While the data from these studies is helpful, no study has been able to adequately identify and assess accurate predictors of HF class.

Current efficacious management strategies are limited to hemodynamic or multisensor monitoring systems. However, these are only available in implanted cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) devices. These are not implanted in every HF patient \[Al-Zaiti, 2019\]. Non-invasive monitoring that provides similar data, such as wearable device monitoring, would expand the cohort of patients that would benefit from remote monitoring and would avoid the risks of having implanted hardware. Furthermore, better prediction of HF severity could help guide follow-up care and predict HF events \[Boehmer, 2015; Boehmer 2017\]. This would lead to more efficient management, less hospital readmission, and improve outcomes for HF patients overall \[Dickinson, 2018\].

The investigators propose a feasibility study in HF patients to better assess HF disease state, which can aid in management and improve outcomes. Subjects will wear the WHOOP device, which measures both activity and HR parameters and can derive RR using respiratory sinus arrhythmia, for 90 days. During this period, their HR and RR will be recorded at rest, during activity and post-activity recovery phases. This combined measure of HR/RR has been shown to predict NYHA HF class, an indicator of severity of disease, in implantable devices with multi-sensor monitoring capabilities; thus, it represents a useful management strategy in HF patients \[Bullinga, 2005; Tsuji, 1996\]. A continuous external monitoring device worn on the wrist, such as the WHOOP device, would provide valuable physiologic data for a cohort of HF patients who were previously unable to be monitored in this fashion. Secondary analysis of this study will investigate the use of intra- and post-activity HR and RR as predictors of hospitalization rates, a common problem in HF patients that correlate with worse mortality outcomes.

Eligibility criteria: Inclusion Criteria:

1. Subject has provided informed consent
2. Male or female over the age of 18 years
3. The patient is either hospitalized with a primary diagnosis of acute heart failure or was discharged with a primary diagnosis of acute heart failure within 2 weeks prior to enrollment; or carries a diagnosis of heart failure and is seen as an outpatient at Hershey Medical Center.
4. NYHA functional class II-IV at time of enrollment
5. Subject willing to wear the WHOOP for the 90-day study period.
6. Subject owns a phone for pairing with the WHOOP device (required for data storage and transfer)

Exclusion Criteria:

1. Subjects who are limited by angina.
2. Subjects with severe aortic stenosis.
3. Subjects who are hemodynamically unstable requiring support with intravenous vasoactive medications or mechanical circulatory support
4. Subjects with symptomatic ventricular arrhythmias within the past 6 months.

Primary outcomes:
measure: Daily average heart rate (HR)
timeFrame: 90 days
measure: Daily average respiratory rate (RR)
timeFrame: 90 days
measure: Heart Failure (HF) hospitalizations
timeFrame: 90 days
Secondary outcomes:
measure: Average HR isolated during any activity
timeFrame: 90 days
measure: Max HR isolated during any activity
timeFrame: 90 days
measure: Average RR isolated during any activity
timeFrame: 90 days
measure: Max RR isolated during any activity
timeFrame: 90 days
measure: New York Heart Association (NYHA) functional HF class
timeFrame: 90 days
measure: 6-minute walk test
timeFrame: 90 days
measure: NT-proBNP (N-terminal-pro hormone B-type natriuretic peptide)
timeFrame: 90 days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: John Boehmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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