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TerminatedNCT04550052A-SPIRE-HFUpdated Jun 3, 2026

A-SPIRE Heart Failure: Utilizing Health Tags to Identify Patients at Risk for Hospital Readmissions

An observational study in Heart Failure, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by University of Rochester · Observational

Why this study was terminated
Initial sample sufficient for analysis
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the use of the Spire Health Tags in heart failure patients to determine the feasibility of capturing signals of respiration, pulse rate, activity, sleep patterns, and stress levels following HF hospitalization.

Read the detailed description

Over 5 million Americans suffer from heart failure (HF), and treating HF as a chronic condition is associated with significant costs. In addition, about 24% of the patients discharged with a primary diagnosis of HF are readmitted to the hospital within 30 days, representing a significant public health burden. While there have been efforts to predict and reduce 30-day hospital readmission initiated by the Centers for Medicare and Medicaid Services (CMS), no studies utilized daily physiologic data from wearables to identify at-risk patients.

The overall goal of this proposed pilot feasibility study is to utilize the Spire Health Tags in a heart failure patient population to ascertain the feasibility of capturing appropriate signals of respiration, pulse rate, activity, sleep patterns, and stress levels (calm/focused/tense during the day) for > 80% of the time in patients following HF hospitalization for a 30-day period. The investigators will do exploratory analysis of the changes in these physiologic variables during a 30-day period following HF hospitalization to identify risk markers that could predict 30-day readmission.

02

Conditions studied

  • Heart Failure

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Keywords

  • Spire Health Tag
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 36 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients discharged following heart failure hospitalization,

Inclusion criteria

  • Men and women 18 years of age or older;
  • Admitted for acute heart failure;
  • Expected to be discharged from hospitalization;
  • Able to give consent;
  • Willing to use the Spire Health Tags for 30 days continuously.

Exclusion criteria

Exclusion Criteria:

  • Unable or unwilling to participate in the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To ascertain the feasibility of capturing appropriate signals of pulse rate for > 80% of the time in patients following HF hospitalization for a 30-day period.

    We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.

    Time frame: 30 Days

  2. To ascertain the feasibility of capturing appropriate signals of activity for > 80% of the time in patients following HF hospitalization for a 30-day period.

    We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.

    Time frame: 30 Days

  3. To ascertain the feasibility of capturing appropriate signals of sleep patterns for > 80% of the time in patients following HF hospitalization for a 30-day period.

    We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.

    Time frame: 30 Days

  4. To ascertain the feasibility of capturing appropriate signals of stress levels (calm/focused/tense during the day) for > 80% of the time in patients following HF hospitalization for a 30-day period.

    We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.

    Time frame: 30 Days

07

Study locations

1 site
  • University of Rochester
    Rochester, New York 14642, United States
08

References and documents

Publications

  • Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available. PubMed 24446411 ↗
  • Keenan PS, Normand SL, Lin Z, Drye EE, Bhat KR, Ross JS, Schuur JD, Stauffer BD, Bernheim SM, Epstein AJ, Wang Y, Herrin J, Chen J, Federer JJ, Mattera JA, Wang Y, Krumholz HM. An administrative claims measure suitable for profiling hospital performance on the basis of 30-day all-cause readmission rates among patients with heart failure. Circ Cardiovasc Qual Outcomes. 2008 Sep;1(1):29-37. doi: 10.1161/CIRCOUTCOMES.108.802686. PubMed 20031785 ↗
  • Dharmarajan K, Hsieh AF, Lin Z, Bueno H, Ross JS, Horwitz LI, Barreto-Filho JA, Kim N, Bernheim SM, Suter LG, Drye EE, Krumholz HM. Diagnoses and timing of 30-day readmissions after hospitalization for heart failure, acute myocardial infarction, or pneumonia. JAMA. 2013 Jan 23;309(4):355-63. doi: 10.1001/jama.2012.216476. PubMed 23340637 ↗
  • Amarasingham R, Patel PC, Toto K, Nelson LL, Swanson TS, Moore BJ, Xie B, Zhang S, Alvarez KS, Ma Y, Drazner MH, Kollipara U, Halm EA. Allocating scarce resources in real-time to reduce heart failure readmissions: a prospective, controlled study. BMJ Qual Saf. 2013 Dec;22(12):998-1005. doi: 10.1136/bmjqs-2013-001901. Epub 2013 Jul 31. PubMed 23904506 ↗
  • Fang J, Wylie-Rosett J, Cohen HW, Kaplan RC, Alderman MH. Exercise, body mass index, caloric intake, and cardiovascular mortality. Am J Prev Med. 2003 Nov;25(4):283-9. doi: 10.1016/s0749-3797(03)00207-1. PubMed 14580628 ↗
  • Seefeldt V, Malina RM, Clark MA. Factors affecting levels of physical activity in adults. Sports Med. 2002;32(3):143-68. doi: 10.2165/00007256-200232030-00001. PubMed 11839079 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04550052
Lead sponsor
University of Rochester
Collaborators
Spire, Inc.
Responsible party
Valentina Kutyifa (Associate Professor of Medicine (Cardiology), University of Rochester) — Principal investigator
First posted
Sep 16, 2020
Start date
Aug 13, 2020
Primary completion
Aug 1, 2025
Completion
Aug 1, 2025
Last update
Jun 3, 2026

Study contacts

Valentina Kutyifa, MD, PhD
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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