Reassure Remote Respiration Monitoring in Heart Failure Patients
Heart Failure
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring respiration rate, sleep
Eligibility Criteria
Inclusion Criteria:
- Males or females age ≥18 years old
- Patients admitted to hospital for worsening of heart failure; Worsening of heart failure is defined as symptoms consistent with worsening of heart failure, including dyspnea and an elevated BNP. Patients must have existing diagnosis of heart failure, either preserved ejection fraction or reduced ejection fraction (HFpEF or HFrEF)
- Weight ≥35 kg
- Pre-Menopausal Women ≥18 years of age must have a negative urine/serum pregnancy test or pre-menopausal women with evidence of surgical sterilization or post-menopausal women.
- Must qualify for standard home care post discharge
- Must be able to read and understand English and consent for themselves
Exclusion Criteria:
- Under 18 years of age
- Participant is on a form of non-invasive positive airway pressure ventilation (in such cases, respiratory rates and variability will reflect combined physiology plus machine effect)
- Participant has an existing diagnosis in the medical record for sleep disordered breathing, whether on therapy or not
- Participant has cognitive impairment (determined by physician) that will make it hard for them to follow instructions regarding therapy usage
- BMI> 40
- Patients who are discharged to hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
- Patients who are actively being monitored using a pulmonary arterial pressure monitor (CardioMEMs)
- Patients with COPD GOLD Stage III or IV
- Planned procedures at time of discharge that will occur within timeframe of study that will require hospitalization etc.
- Participant declines to participate at any time.
- Patients involved in therapy intervention clinical trials
- Any investigational drug use within 30 days prior to enrollment.
- Pregnant or lactating females.
- Participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
- Participants who have no cellular coverage at their primary residence
Sites / Locations
- Allegheny General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention
Control
Reassure Non-Contact Respiration Monitor: Respiration parameters transmitted by the Reassure device will be evaluated daily by the study team and participants will be contacted for further evaluation if a change in respiration patterns is noted. Participants will continue with standard of care heart failure treatment.
Reassure Non-Contact Respiration Monitor: Respiration parameters will be transmitted and stored, but there will be no active evaluation of respiration patterns. Participants will continue with standard of care heart failure treatment.