A multi-center study to discern the diurnal variation of wearable device-based heart rate variability (HRV) in the Chronic Renal Insufficiency Cohort (CRIC) Study

Abstract

Little is known about the prognostic value of out-of-clinic biometric monitoring of cardiovascular function in chronic kidney disease (CKD). Using real-world sampling strategies, a mean (±SD) of 50.3±9.3 hours of ECG recordings from wearable BioPatch ECG devices was collected in a cohort consisting of 458 participants from seven Chronic Renal Insufficiency Cohort (CRIC) centers. The presence of diabetes was associated with a 7.4 ms lower Standard Deviation of NN Intervals (SDNN) compared to non-diabetic participants (p=0.001). Multivariable linear regression revealed that participants without proteinuria (uPCR<0.2) had a 5.15 ms higher SDNN compared to participants with proteinuria (uPCR≥0.2, p=0.027). Cosinor modeling suggested differences in SDNN acrophase quartiles for diabetes (p=0.02), history of cardiovascular disease (p=0.003), eGFR (p=0.04), systolic blood pressure (p=0.04), and beta blocker use (p=0.0002). In the spline analysis, the SDNN curve differed between participants with and without cardiovascular disease (p=0.0005). This study assembled the largest dataset to date of SDNN as an index for heart rate variability from wearable digital health technology in the CRIC. The study demonstrates that several clinical and demographic factors are associated with SDNN in participants with CKD. This sets the stage to determine the predictiveness of time-specific HRV metrics for future clinical outcomes.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

Funding for the CRIC Study was obtained under a cooperative agreement from National Institute of Diabetes and Digestive and Kidney Diseases (U01DK060990, U01DK060984, U01DK061022, U01DK061021, U01DK061028, U01DK060980, U01DK060963, U01DK060902 and U24DK060990). In addition, this work was supported in part by: the Perelman School of Medicine at the University of Pennsylvania Clinical and Translational Science Award NIH/NCATS UL1TR000003, Johns Hopkins University UL1 TR-000424, University of Maryland GCRC M01 RR-16500, Clinical and Translational Science Collaborative of Cleveland, UL1TR000439 from the National Center for Advancing Translational Sciences (NCATS) component of the National Institutes of Health and NIH roadmap for Medical Research, Michigan Institute for Clinical and Health Research (MICHR) UL1TR000433, University of Illinois at Chicago CTSA UL1RR029879, Tulane COBRE for Clinical and Translational Research in Cardiometabolic Diseases P20 GM109036, Kaiser Permanente NIH/NCRR UCSF-CTSI UL1 RR-024131, Department of Internal Medicine, University of New Mexico School of Medicine Albuquerque, NM R01DK119199. CS is the Robert L McNeil Jr. Endowed Fellow in Translational Medicine and Therapeutics.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The IRB at each participating study sites gave ethical approval for this work. * University of Pennsylvania Institutional Review Board (Federalwide Assurance # 00004028), for CRIC Phase 5, the University of Pennsylvania IRB serves as the central IRB. * Johns Hopkins Institutional Review Board, Study # NA_00044034 / CIR00004697 * The University of Maryland, Baltimore Institutional Review Board * University Hospitals Cleveland Medical Center Institutional Review Board * MetroHealth Institutional Review Board * Cleveland Clinic Foundation Institutional Review Board IRB #5969 * University of Michigan Medical School Institutional Review Board (IRBMED) * Wayne State University Institutional Review Board * University of Illinois at Chicago Institutional Review Board * Tulane Human Research Protection Office, Institutional Review Boards, Biomedical Social Behavioral , IRB REFERENCE #: 140987 * Kaiser Permanente Northern California (KPNC) Institutional Review Board (IRB)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Footnotes

11 Lawrence J. Appel, MD, MPH; Debbie L Cohen, MD; Laura M Dember, MD; Alan S. Go, MD, Panduranga S. Rao, MD

Data Availability

All data produced in the present study are available upon reasonable request from the CRIC Study Investigators.

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