Heart Failure Clinical Trial
Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events
Summary
The main goal of this study is to use data from the Bodyport scale to help detect of worsening heart failure (HF) early.
Full Description
The overarching goal of this prospective, multicenter study is to utilize data from the Bodyport scale to develop an index that allows for the early detection of worsening heart failure (HF). The Bodyport 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 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.
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 8 Locations for this study
Boynton Beach Florida, 33472, United States
Panama City Florida, 32405, United States
Gainesville Georgia, 30501, United States
Kansas City Kansas, 66160, United States
Detroit Michigan, 48201, United States
Durham North Carolina, 27710, United States
Philadelphia Pennsylvania, 19140, United States
Hodges South Carolina, 29653, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.