Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events

NCT04882449 | Completed Results

• 1 other identifier: Pro00107534
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 8

Brief Summary

The main goal of this study is to use data from the Bodyport Cardiac Scale to help detect of worsening heart failure (HF) early.

Conditions

Heart Failure

Keywords

Bodyport; Heart Failure; Decompensation

Outcome Measures

Primary Outcomes (1)

• Number of Usable Worsening HF Events as Adjudicated by CEC

  Worsening HF will be defined as a composite of the following: urgent, unscheduled clinic or emergency department visit or hospital admission with a primary diagnosis of HF in which the patient exhibited new or worsening symptoms of HF on presentation, had objective evidence of new or worsening HF, and received initiation or intensification of treatment for HF.

  Approximately 1 year

Study Arms (1)

Bodyport Cardiac Scale

All subjects will be given the Bodyport Cardiac Scale to use

Device: Bodyport Cardiac Scale

Interventions

Bodyport Cardiac Scale DEVICE

The Bodyport Cardiac Scale is capable of measuring key HF parameters of congestion and cardiac perfusion on a regular basis in a patient's home. These data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening HF.

Also known as: Bodyport Inc.

Bodyport Cardiac Scale

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 200-300 male and female participants in the US, 18 years of age or older, irrespective of left ventricular ejection fraction with symptomatic HF will be enrolled. Patients must be able to stand independently on the Bodyport scale.

You may qualify if:

• Provide informed consent before trial enrollment
• Age ≥ 18 years
• A diagnosis of symptomatic HF including a worsening HF event in the preceding 12 months. Worsening HF events will be determined by local clinician-investigators and will typically include the following: a) HF symptoms (eg, dyspnea, fatigue); b) HF signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the event, and treatments targeting acute HF (eg, intravenous diuretics, vasodilators, or inotropes).

You may not qualify if:

• Weight \>170 kg
• Use of chronic inotropic therapy
• Prior heart transplant or currently listed for heart transplant
• Current or planned left ventricular assistance device
• Chronic kidney disease requiring chronic dialysis
• Unknown left ventricular ejection fraction (LVEF). The LVEF should be based on the most recent local measurement using echocardiography, multigated acquisition scan, computed tomography scanning, magnetic resonance imaging, or ventricular angiography. Patients with preserved and reduced LVEF will be permitted in the study though enrollment may be capped to ensure no more than approximately 2/3 of the total enrollment includes patients with preserved or reduced LVEF.
• Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
• Unable to participate in longitudinal follow-up including daily use of the Bodyport scale. Patients must be able to stand independently on the Bodyport scale.

Sponsors & Collaborators

• Bodyport Inc.: lead
• Duke Clinical Research Institute: collaborator

Study Sites (8)

RecioMed Clinical Research Network, Inc.

Boynton Beach, Florida, 33472, United States

Location

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32405, United States

Location

The Heart Center of Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

University of Kansas School of Medicine

Kansas City, Kansas, 66160, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Temple University - Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Self Regional Healthcare Research Center

Hodges, South Carolina, 29653, United States

Location

Related Publications (10)

• Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.

  PMID: 24491689 BACKGROUND

• Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.

  PMID: 29174292 BACKGROUND

• Cleland JG, Charlesworth A, Lubsen J, Swedberg K, Remme WJ, Erhardt L, Di Lenarda A, Komajda M, Metra M, Torp-Pedersen C, Poole-Wilson PA; COMET Investigators. A comparison of the effects of carvedilol and metoprolol on well-being, morbidity, and mortality (the "patient journey") in patients with heart failure: a report from the Carvedilol Or Metoprolol European Trial (COMET). J Am Coll Cardiol. 2006 Apr 18;47(8):1603-11. doi: 10.1016/j.jacc.2005.11.069. Epub 2006 Mar 29.

  PMID: 16630997 BACKGROUND

• Epstein AM, Jha AK, Orav EJ. The relationship between hospital admission rates and rehospitalizations. N Engl J Med. 2011 Dec 15;365(24):2287-95. doi: 10.1056/NEJMsa1101942.

  PMID: 22168643 BACKGROUND

• Cowie MR, Anker SD, Cleland JGF, Felker GM, Filippatos G, Jaarsma T, Jourdain P, Knight E, Massie B, Ponikowski P, Lopez-Sendon J. Improving care for patients with acute heart failure: before, during and after hospitalization. ESC Heart Fail. 2014 Dec;1(2):110-145. doi: 10.1002/ehf2.12021. Epub 2015 Jan 21.

  PMID: 28834628 BACKGROUND

• Soundarraj D, Singh V, Satija V, Thakur RK. Containing the Cost of Heart Failure Management: A Focus on Reducing Readmissions. Heart Fail Clin. 2017 Jan;13(1):21-28. doi: 10.1016/j.hfc.2016.07.002.

  PMID: 27886926 BACKGROUND

• Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• Ozonat K, Centen C, Smith S, Aydemir VB, Fudim M, DeVore AD. Bioimpedance phase angle is associated with increased heart failure hospitalization risk. Am Heart J. 2026 Feb;292:107288. doi: 10.1016/j.ahj.2025.107288. Epub 2025 Oct 7.

  PMID: 41061788 DERIVED

• Fudim M, Egolum U, Haghighat A, Kottam A, Sauer AJ, Shah H, Kumar P, Rakita V, Lopes RD, Centen C, Ozonat K, Smith S, Pandit J, DeVORE AD. Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events: Results From SCALE-HF 1. J Card Fail. 2025 Apr;31(4):661-675. doi: 10.1016/j.cardfail.2024.08.050. Epub 2024 Sep 17.

  PMID: 39299540 DERIVED

• Fudim M, Yazdi D, Egolum U, Haghighat A, Kottam A, Sauer AJ, Shah H, Kumar P, Rakita V, Centen C, Ozonat K, Smith S, DeVore AD. Use of a Cardiac Scale to Predict Heart Failure Events: Design of SCALE-HF 1. Circ Heart Fail. 2023 May;16(5):e010012. doi: 10.1161/CIRCHEARTFAILURE.122.010012. Epub 2023 May 16.

  PMID: 37192288 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dorothy Kwok, Head of Clinical Operations
• Organization: Bodyport Inc.

dorothy@bodyport.com

669-240-3077

Study Officials

• Adam Devore, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: July 8, 2021
• Primary Completion: April 30, 2023
• Study Completion: July 31, 2023
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)