Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757246
Status:
WITHDRAWN
Last Update Posted:
2022-10-24
First Post:
2021-01-21
Brief Title:
RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF
Sponsor:
WakeMed Health and Hospitals
Organization:
WakeMed Health and Hospitals
Study Overview
Official Title:
RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding from Sponsor did not come through
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPECT
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 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
Detailed Description:
Heart failure HF is becoming increasingly recognized with an estimated worldwide prevalence of 377 million individuals In the United States alone there are over 5 million patients with HF which is expected to increase to over 8 million by 2030 Despite advances in medical therapies and technology HF remains the leading cause of hospitalization among adults and the elderly By 2030 the medical costs of HF are expected to rise from 209 billion to 531 billion with nearly 80 of the projected increased expenses attributes to hospitalization costs As such it is imperative to develop new technologies and treatment options to impact the HF epidemic
The majority of HF hospital admissions are due to volume overload Stiffened andor weakened myocardium predisposes patients to the accumulation of extracellular fluid resulting in increased intracardiac filling pressures and symptoms of congestion edema dyspnea and orthopnea Accurate assessment of a patients volume status remains clinically challenging at times While there have been technological advances in the outpatient monitoring of volume status through thoracic impedance and pulmonary artery pressure monitoring there are no validated non-implantable options for monitoring volume status outside of the physical exam
Aidar Healths MouthLab device is a non-invasive hand-held home monitoring tool that measures multiple medical parameters such as - Temperature Blood Pressure Heart Rate Heart Rate Variability Pulse Rate SpO2 single-lead ECG Respiratory Rate Breathing PatternRespiratory Flow Cycle Morphology and basic lung functions FEV1 FVC FEV1FVC PEF in 30 seconds
The investigators believe that the MouthLab device holds the potential to identify changes in volume status through measurements such as pulse rate oxygen saturation respiratory flow and lung function and accurately predict decompensation in patients with chronic HF The investigators propose the following outline of clinical studies to evaluate the utility of the MouthLab device in HF
The majority of HF hospital admissions are due to volume overload Stiffened andor weakened myocardium predisposes patients to the accumulation of extracellular fluid resulting in increased intracardiac filling pressures and symptoms of congestion edema dyspnea and orthopnea Accurate assessment of a patients volume status remains clinically challenging at times While there have been technological advances in the outpatient monitoring of volume status through thoracic impedance and pulmonary artery pressure monitoring there are no validated non-implantable options for monitoring volume status outside of the physical exam
Aidar Healths MouthLab device is a non-invasive hand-held home monitoring tool that measures multiple medical parameters such as - Temperature Blood Pressure Heart Rate Heart Rate Variability Pulse Rate SpO2 single-lead ECG Respiratory Rate Breathing PatternRespiratory Flow Cycle Morphology and basic lung functions FEV1 FVC FEV1FVC PEF in 30 seconds
The investigators believe that the MouthLab device holds the potential to identify changes in volume status through measurements such as pulse rate oxygen saturation respiratory flow and lung function and accurately predict decompensation in patients with chronic HF The investigators propose the following outline of clinical studies to evaluate the utility of the MouthLab device in HF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None