RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF
- Conditions
- Heart Failure
- Interventions
- Other: MouthLab Device
- Registration Number
- NCT04757246
- Lead Sponsor
- WakeMed Health and Hospitals
- 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 \>37.7 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 $20.9 billion to $53.1 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 and/or 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 patient's 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 Health's 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 Pattern/Respiratory Flow Cycle Morphology, and basic lung functions (FEV1, FVC, FEV1/FVC, 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 MouthLab Device Stable outpatients with implantable CardioMEMS devices Cohort 1 MouthLab Device Stable outpatients without implantable devices Cohort 2 MouthLab Device Stable outpatients with Boston Scientific pacemakers or defibrillators with Heart Logic capability
- Primary Outcome Measures
Name Time Method Measuring FEV1/FVC as a ratio 6 months Determining Lung Function
Evaluate trends of temperature measured in Fahrenheit 6 months Temperature
Evaluate trends of respiration rate per minute 6 months Respiration rate measured by breaths taken per minute
Aidar Questionnaire to Evaluate Patient Perception of Heart Failure 6 months The Aidar Questionnaire will be used to determine patient perception of severity of heart failure.
Evaluating the QRS complex on electrocardiogram in milliseconds 6 months QRS complex will be measured to determine heart rhythm
Evaluating the T wave on electrocardiogram in milliseconds 6 months T wave will be measured to determine heart rhythm
Evaluate trends of blood pressure measured in mm/Hg 6 months Blood pressure
Evaluate trends of blood oxygen saturation (SpO2) in percentage 6 months blood oxygen saturation (SpO2)
Evaluate trends of pulse rate per minute 6 month Pulse rate
Evaluating the P wave of electrocardiogram in milliseconds 6 months P wave on electrocardiogram will be measured to determine heart rhythm
Measuring FEV1 (Forced Expiratory Volume) in Liters 6 months Determining Lung Function
Measuring FVC (Forced Vital Capacity) in Liters 6 months Determining Lung Function
Measuring PEF (Peak Expiratory Flow) in Liters/second 6 months Determining Lung Function
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
WakeMed Health and Hospitals
🇺🇸Raleigh, North Carolina, United States