RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF

Study Overview
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Brief Summary
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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
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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.

Official Title
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RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF

Conditions
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Heart Failure

Intervention / Treatment
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* Other: MouthLab Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>Stable outpatients without implantable devices | Other: MouthLab Device<br>* Use of MouthLab system<br>|
| Other: Cohort 2<br>Stable outpatients with Boston Scientific pacemakers or defibrillators with Heart Logic capability | Other: MouthLab Device<br>* Use of MouthLab system<br>|
| Other: Cohort 3<br>Stable outpatients with implantable CardioMEMS devices | Other: MouthLab Device<br>* Use of MouthLab system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate trends of respiration rate per minute | Respiration rate measured by breaths taken per minute | 6 months | 
| Aidar Questionnaire to Evaluate Patient Perception of Heart Failure | The Aidar Questionnaire will be used to determine patient perception of severity of heart failure. | 6 months | 
| Evaluate trends of temperature measured in Fahrenheit | Temperature | 6 months | 
| Evaluate trends of pulse rate per minute | Pulse rate | 6 month | 
| Evaluating the P wave of electrocardiogram in milliseconds | P wave on electrocardiogram will be measured to determine heart rhythm | 6 months | 
| Evaluating the QRS complex on electrocardiogram in milliseconds | QRS complex will be measured to determine heart rhythm | 6 months | 
| Evaluating the T wave on electrocardiogram in milliseconds | T wave will be measured to determine heart rhythm | 6 months | 
| Evaluate trends of blood pressure measured in mm/Hg | Blood pressure | 6 months | 
| Evaluate trends of blood oxygen saturation (SpO2) in percentage | blood oxygen saturation (SpO2) | 6 months | 
| Measuring FEV1 (Forced Expiratory Volume) in Liters | Determining Lung Function | 6 months | 
| Measuring FVC (Forced Vital Capacity) in Liters | Determining Lung Function | 6 months | 
| Measuring FEV1/FVC as a ratio | Determining Lung Function | 6 months | 
| Measuring PEF (Peak Expiratory Flow) in Liters/second | Determining Lung Function | 6 months |