Heart FailureSCALE-HF1NCT04882449
Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events
An observational study of Heart Failure, run by Bodyport Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Bodyport Cardiac Scale
- Type of treatment
- Medical device
- How many people
- 329 participants
- Where
- 8 sitesUnited States
- Study dates
- 8 Jul 2021to 31 Jul 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, 33472
Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
The Heart Center of Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Self Regional Healthcare Research Center
Hodges, South Carolina, 29653
University of Kansas School of Medicine
Kansas City, Kansas, 66160
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405
Temple University - Lewis Katz School of Medicine
Philadelphia, Pennsylvania, 19140
About this study
Official title: Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events - SCALE-HF1
The main goal of this study is to use data from the Bodyport Cardiac Scale to help detect of worsening heart failure (HF) early.
Read the detailed description
The overarching goal of this prospective, multicenter study is to utilize data from the Bodyport Cardiac Scale to develop an index that allows for the early detection of worsening heart failure (HF). 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.
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
- Heart Failure
- Being tested
- Bodyport Cardiac Scale
- Keywords
- Bodyport, Heart Failure, Decompensation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodyport Cardiac ScaleDevice
Also called Bodyport Inc.
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.
| Study group | Role | What they receive |
|---|---|---|
| Bodyport Cardiac Scale | All subjects will be given the Bodyport Cardiac Scale to use Receives: Device: Bodyport Cardiac Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start8 Jul 2021
- Primary completion30 Apr 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bodyport Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Adam Devore, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882449
- Sponsor's protocol ID
- Pro00107534
- Acronym
- SCALE-HF1
- Status last verified
- Feb 2025
- First submitted
- 6 May 2021
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
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.
PubMed 24491689Conrad 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.
PubMed 29174292Cleland 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.
PubMed 16630997Epstein 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.
PubMed 22168643Cowie 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.
PubMed 28834628Soundarraj 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.
PubMed 27886926Benjamin 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.
PubMed 28122885Ozonat 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.
PubMed 41061788Fudim 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.
PubMed 39299540Fudim 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.
PubMed 37192288
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events - SCALE-HF1
- ClinicalTrials.gov ID
- NCT04882449
- Acronym / sponsor ID
- SCALE-HF1 / Pro00107534
- Conditions
- Heart Failure
- Keywords
- Bodyport, Heart Failure, Decompensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Bodyport Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to use data from the Bodyport Cardiac Scale to help detect of worsening heart failure (HF) early.
Detailed description
The overarching goal of this prospective, multicenter study is to utilize data from the Bodyport Cardiac Scale to develop an index that allows for the early detection of worsening heart failure (HF). 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bodyport Cardiac Scale | – | Device: Bodyport Cardiac ScaleAll subjects will be given the Bodyport Cardiac Scale to use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodyport Cardiac ScaleAlso: Bodyport Inc.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. | Device | Bodyport Cardiac Scale |
Primary outcome
Number of Usable Worsening HF Events as Adjudicated by CEC
Time frame: Approximately 1 year
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24491689Ambrosy 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.
- Background: PubMed 29174292Conrad 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.
- Background: PubMed 16630997Cleland 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.
- Background: PubMed 22168643Epstein 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.
- Background: PubMed 28834628Cowie 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.
- Background: PubMed 27886926Soundarraj 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.
- Background: PubMed 28122885Benjamin 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.
- Derived from this study: PubMed 41061788Ozonat 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.
- Derived from this study: PubMed 39299540Fudim 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.
- Derived from this study: PubMed 37192288Fudim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Devore, MD principal investigator
Duke Clinical Research Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Bodyport Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Usable Worsening HF Events as Adjudicated by CEC (time frame: Approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882449, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.