Wearable Remote Monitoring of Heart Rate and Respiratory Rate for Heart Failure

NCT04455828 | Withdrawn

• 1 other identifier: STUDY15557
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction

Keywords

Heart Failure; Remote Monitoring; WHOOP strap 3.0

Outcome Measures

Primary Outcomes (3)

• Daily average heart rate (HR)

  Daily average heart rate (HR) measured by the WHOOP device. This will be continuously measured for 90 days.

  90 days

• Daily average respiratory rate (RR)

  Daily average respiratory rate (RR) measured by the WHOOP device. This will be continuously measured for 90 days

  90 days

• Heart Failure (HF) hospitalizations

  Hospital admission for the primary diagnosis for acute, or acute on chronic heart failure) will be assessed via Electronic Medical Record (EMR) and a 90-day patient follow up visit.

  90 days

Secondary Outcomes (7)

• Average HR isolated during any activity

  90 days

• Max HR isolated during any activity

  90 days

• Average RR isolated during any activity

  90 days

• Max RR isolated during any activity

  90 days

• New York Heart Association (NYHA) functional HF class

  90 days

Study Arms (2)

Hospitalized Heart Failure subjects

Subjects hospitalized for heart failure exacerbation will be enrolled, prior to discharge from hospital, to wear the WHOOP device for 90 days.

Device: WHOOP strap 3.0

Non-hospitalized Heart Failure subjects

Subjects who have not been hospitalized in the past 1 year, but have a diagnosis of heart failure, will be enrolled during routine outpatient care to wear the WHOOP device for 90 days.

Device: WHOOP strap 3.0

Interventions

WHOOP strap 3.0 DEVICE

WHOOP strap 3.0, a photodiode-based device that tracks heart rate, respiratory rate, sleep, and heart rate variability.

Hospitalized Heart Failure subjects; Non-hospitalized Heart Failure subjects

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject has provided informed consent
• Male or female over the age of 18 years
• 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.
• NYHA functional class II-IV at time of enrollment
• Subject willing to wear the WHOOP for the 90-day study period.
• Subject owns a phone for pairing with the WHOOP device (required for data storage and transfer)

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (13)

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  PMID: 20177011 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Card Fail. 2017 Aug;23(8):628-651. doi: 10.1016/j.cardfail.2017.04.014. Epub 2017 Apr 28. No abstract available.

  PMID: 28461259 BACKGROUND

• Ross JS, Chen J, Lin Z, Bueno H, Curtis JP, Keenan PS, Normand SL, Schreiner G, Spertus JA, Vidan MT, Wang Y, Wang Y, Krumholz HM. Recent national trends in readmission rates after heart failure hospitalization. Circ Heart Fail. 2010 Jan;3(1):97-103. doi: 10.1161/CIRCHEARTFAILURE.109.885210. Epub 2009 Nov 10.

  PMID: 19903931 BACKGROUND

• Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM. Patterns of weight change preceding hospitalization for heart failure. Circulation. 2007 Oct 2;116(14):1549-54. doi: 10.1161/CIRCULATIONAHA.107.690768. Epub 2007 Sep 10.

  PMID: 17846286 BACKGROUND

• Dickinson MG, Allen LA, Albert NA, DiSalvo T, Ewald GA, Vest AR, Whellan DJ, Zile MR, Givertz MM. Remote Monitoring of Patients With Heart Failure: A White Paper From the Heart Failure Society of America Scientific Statements Committee. J Card Fail. 2018 Oct;24(10):682-694. doi: 10.1016/j.cardfail.2018.08.011. Epub 2018 Oct 9.

  PMID: 30308242 BACKGROUND

• Auricchio A, Gold MR, Brugada J, Nolker G, Arunasalam S, Leclercq C, Defaye P, Calo L, Baumann O, Leyva F. Long-term effectiveness of the combined minute ventilation and patient activity sensors as predictor of heart failure events in patients treated with cardiac resynchronization therapy: Results of the Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT device Trial (CLEPSYDRA) study. Eur J Heart Fail. 2014 Jun;16(6):663-70. doi: 10.1002/ejhf.79. Epub 2014 Mar 17.

  PMID: 24639140 BACKGROUND

• Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.

  PMID: 28254128 BACKGROUND

• Al-Zaiti SS, Pietrasik G, Carey MG, Alhamaydeh M, Canty JM, Fallavollita JA. The role of heart rate variability, heart rate turbulence, and deceleration capacity in predicting cause-specific mortality in chronic heart failure. J Electrocardiol. 2019 Jan-Feb;52:70-74. doi: 10.1016/j.jelectrocard.2018.11.006. Epub 2018 Nov 6.

  PMID: 30476644 BACKGROUND

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  PMID: 29034226 BACKGROUND

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  PMID: 16360965 BACKGROUND

• Tsuji H, Larson MG, Venditti FJ Jr, Manders ES, Evans JC, Feldman CL, Levy D. Impact of reduced heart rate variability on risk for cardiac events. The Framingham Heart Study. Circulation. 1996 Dec 1;94(11):2850-5. doi: 10.1161/01.cir.94.11.2850.

  PMID: 8941112 BACKGROUND

• Berryhill S, Morton CJ, Dean A, Berryhill A, Provencio-Dean N, Patel SI, Estep L, Combs D, Mashaqi S, Gerald LB, Krishnan JA, Parthasarathy S. Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study. J Clin Sleep Med. 2020 May 15;16(5):775-783. doi: 10.5664/jcsm.8356. Epub 2020 Feb 11.

  PMID: 32043961 BACKGROUND

• Sack S, Wende CM, Nagele H, Katz A, Bauer WR, Barr CS, Malinowski K, Schwacke H, Leyva F, Proff J, Berdyshev S, Paul V. Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study. Eur J Heart Fail. 2011 Sep;13(9):1019-27. doi: 10.1093/eurjhf/hfr089.

  PMID: 21852311 BACKGROUND

Related Links

• WHOOP measures heart rate, respiratory rate, Heart Rate Variability (HRV), Resting Heart Rate (RHR), and sleep duration (broken down into sleep stages)..

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• John Boehmer, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: March 1, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)