Heart Failure
Conditions
Keywords
Bodyport, Heart Failure, Decompensation
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.
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.
Interventions
DEVICEBodyport 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.
Sponsors
Duke Clinical Research Institute
Bodyport Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide informed consent before trial enrollment 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
1. Weight \>170 kg 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Usable Worsening HF Events as Adjudicated by CEC | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bodyport Scale All subjects will be given the Bodyport scale to use
Bodyport Scale: 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. | 329 |
| Total | 329 |
Baseline characteristics
| Characteristic | Bodyport Scale |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 14 |
| Body Mass Index (BMI) | 31.8 kg/m^2 STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 319 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Left Ventricular Ejection Fraction <=40% | 183 Participants |
| Left Ventricular Ejection Fraction 41-49% | 25 Participants |
| Left Ventricular Ejection Fraction >=50 | 118 Participants |
| Left Ventricular Ejection Fraction Unknown | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 107 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 210 Participants |
| Sex: Female, Male Female | 142 Participants |
| Sex: Female, Male Male | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 26 / 329 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Approximately 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bodyport Scale | Number of Usable Worsening HF Events as Adjudicated by CEC | 69 Adjudicated Events |