RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF
Withdrawn before enrolling · Not applicable
Conditions studied: Heart Failure
In brief
The goal is to evaluate the trends in MouthLab parameters (respiration rate, temperature, pulse rate, electrocardiogram rhythm, blood pressure, oxygen saturation heart rate and basic lung function measures) in patients with decompensated heart failure and how these measurements change in response to decongestion. The research will test the ability of the MouthLab device to predict clinical decompensation in patients with known heart failure and to reduce the number of hospital readmissions based on the treatment guided by MouthLab device data.
Key facts
- Study ID
- NCT04757246
- Run by
- WakeMed Health and Hospitals
- People needed
- 0
- Starts
- 2022-10-01
- Expected to finish
- 2022-10-20
- Last updated by the study team
- 2022-10-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged ≥ 18 years old
- Willing and able to provide informed consent
- Admitted within previous 24 hours with HF exacerbation requiring intravenous diuretic therapy (reduced or preserved ejection fraction)
- English speaking
You may not qualify if…
- Currently on dialysis
- Patients with acute coronary syndrome
- Currently on hospice
- Have a heart transplant or left ventricular assist device
- Outpatient Sub-Study Eligibility Criteria
- Inclusion Criteria
- Adults aged ≥ 18 years old
- Willing and able to provide informed consent
- Patients presenting to the clinic and not being admitted to the hospital, who have been admitted for a HF exacerbation within the past 6 months, OR patients being discharged from a HF exacerbation related inpatient hospitalization
- For inclusion in Cohort 2, patients must have Boston Scientific pacemaker or defibrillator with Heart Logic capability
- For inclusion in Cohort 3, patients must have implantable CardioMEMS device
- Patients currently on inotropes
- English speaking
- Exclusion Criteria
- Currently on dialysis
- Currently on hospice
- Have a heart transplant or left ventricular assist device
Where it is running
- WakeMed Health and Hospitals — Raleigh, North Carolina, United States
Full record on ClinicalTrials.gov
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