Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events
NCT ID: NCT04882449
Last Updated: 2025-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
329 participants
OBSERVATIONAL
2021-07-08
2023-07-31
Brief Summary
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Detailed Description
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The SCALE-HF program will consist of multiple phases. For SCALE-HF 1, patients will be prospectively enrolled and utilize the Bodyport Cardiac Scale on a daily basis. Patients and clinicians will be blinded to the results other than data readily available from other devices such as body weight. There will be no attempt to influence clinical practice. Patients will be followed remotely for suspected clinical events.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bodyport Cardiac Scale
All subjects will be given the Bodyport Cardiac Scale to use
Bodyport Cardiac Scale
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.
Interventions
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Bodyport Cardiac Scale
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. 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).
Exclusion Criteria
2. Use of chronic inotropic therapy
3. Prior heart transplant or currently listed for heart transplant
4. Current or planned left ventricular assistance device
5. Chronic kidney disease requiring chronic dialysis
6. 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.
7. 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
8. 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.
18 Years
ALL
No
Sponsors
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Duke Clinical Research Institute
OTHER
Bodyport Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Devore, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
The Heart Center of Northeast Georgia Medical Center
Gainesville, Georgia, United States
University of Kansas School of Medicine
Kansas City, Kansas, United States
Wayne State University
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Temple University - Lewis Katz School of Medicine
Philadelphia, Pennsylvania, United States
Self Regional Healthcare Research Center
Hodges, South Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Ozonat K, Centen C, Smith S, Aydemir B, Fudim M, DeVore AD. Bioimpedance phase angle is associated with increased heart failure hospitalization risk. Am Heart J. 2025 Oct 6:107288. doi: 10.1016/j.ahj.2025.107288. Online ahead of print.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Pro00107534
Identifier Type: -
Identifier Source: org_study_id
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