Reassure Remote Respiration Monitoring in Heart Failure Patients

Stopped early · Not applicable

Conditions studied: Heart Failure

In brief

This study is designed to descriptively assess improvement in quality of life and test the usability of remotely monitored respiration parameters in the routine management of recently discharged heart failure patients. It will consist of two arms: (i) intervention, and (ii) control. Participants will be randomized to either arm at time of enrollment. Every participant enrolled in the study will receive a device for remote monitoring.

Key facts

Study ID

NCT02624739

Run by

ResMed

People needed

17

Starts

2015-12-01

Expected to finish

2016-07-01

Last updated by the study team

2021-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.