Status:
WITHDRAWN
RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF
Lead Sponsor:
WakeMed Health and Hospitals
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 mea...
Detailed Description
Heart failure (HF) is becoming increasingly recognized with an estimated worldwide prevalence of \>37.7 million individuals. In the United States alone, there are over 5 million patients with HF which...
Eligibility Criteria
Inclusion
- Inpatient Sub-Study Eligibility Criteria
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04757246
Start Date
October 1 2022
End Date
October 20 2022
Last Update
October 24 2022
Active Locations (1)
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1
WakeMed Health and Hospitals
Raleigh, North Carolina, United States, 27610