Adherent Monitoring of Congestive Heart Failure during Therapy for Excess Fluid (ACUTE) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To gather data to correlate physiological signals with the patient?s fluid status and heart failure symptoms during recovery from acute heart failure decompensation.
Study Overview
Brief Summary
This is a prospective, multi-center, non-randomized study. Patients who have been admitted to the hospital with fluid overload will be enrolled into the study and monitored with the investigational device for up to 2 weeks. The system will continuously record physiologic variables such as heart rate, fluid conductance, activity and respiration.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Potential patients must meet all of the following criteria: 1.Is female or male, 18 years of age or older 2.Has an ejection fraction of 40% reported within 12 months of enrollment 3.Have acute decompensated heart failure and receiving treatment for fluid overload 4.Is willing to provide written informed consent and comply with study guidelines.
Exclusion Criteria
- •Patients will be excluded from the study if they meet any of the following criteria1.Has an implantable device with an active minute ventilation sensor 2.Has a known allergy or hypersensitivity to adhesives or hydrogel3.Has received the first treatment for this episode of acute heart failure decompensation more than 24 hours ago4.Is participating in another clinical study that may confound the results of this study.
Outcomes
Primary Outcomes
To gather data to correlate physiological signals with the patient?s fluid status and heart failure symptoms during recovery from acute heart failure decompensation.
Time Frame: Analyses in addition to the primary endpoint analysis will include:ii) Summarizing the incidence and frequency of all adverse events reported during the study. Events will be classified by the study sites into adverse events, serious adverse events (SAEs), and/or unanticipated adverse device effects (UADEs). Severity of each event will be classified as mild, moderate or severe. The relationship to the investigational device will be determined using a classification of Definite, Probable, Possible or None. The number and percent of patients experiencing each event will be presented with the number and percent of the following: SAE, UADE, moderate events, severe events, definitely related events, probably related events and possibly related events.
Secondary Outcomes
No secondary outcomes reported