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

Heart Failure Clinical Trial

— RESPECT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04757246
• Other study ID #: 1705978
• Status: Withdrawn
• Phase: N/A
• Start date: October 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: October 2022
• Source: WakeMed Health and Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 20, 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inpatient Sub-Study Eligibility Criteria

Inclusion Criteria

1. Adults aged = 18 years old

2. Willing and able to provide informed consent

3. Admitted within previous 24 hours with HF exacerbation requiring intravenous diuretic therapy (reduced or preserved ejection fraction)

4. English speaking

Exclusion Criteria

1. Currently on dialysis

2. Patients with acute coronary syndrome

3. Currently on hospice

4. Have a heart transplant or left ventricular assist device

• Outpatient Sub-Study Eligibility Criteria

Inclusion Criteria

1. Adults aged = 18 years old

2. Willing and able to provide informed consent

3. 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

4. For inclusion in Cohort 2, patients must have Boston Scientific pacemaker or defibrillator with Heart Logic capability

5. For inclusion in Cohort 3, patients must have implantable CardioMEMS device

6. Patients currently on inotropes

7. English speaking

Exclusion Criteria

1. Currently on dialysis

2. Currently on hospice

3. Have a heart transplant or left ventricular assist device

Related Conditions & MeSH terms

• Heart Failure
• Respiratory Insufficiency

Intervention

Other:
• MouthLab Device
Use of MouthLab system

Locations

Country	Name	City	State
United States	WakeMed Health and Hospitals	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
WakeMed Health and Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (6)

Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lic — View Citation

Felker GM, Ellison DH, Mullens W, Cox ZL, Testani JM. Diuretic Therapy for Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 17;75(10):1178-1195. doi: 10.1016/j.jacc.2019.12.059. Review. — View Citation

Garin O, Ferrer M, Pont A, Rué M, Kotzeva A, Wiklund I, Van Ganse E, Alonso J. Disease-specific health-related quality of life questionnaires for heart failure: a systematic review with meta-analyses. Qual Life Res. 2009 Feb;18(1):71-85. doi: 10.1007/s111 — View Citation

Guyatt GH, Nogradi S, Halcrow S, Singer J, Sullivan MJ, Fallen EL. Development and testing of a new measure of health status for clinical trials in heart failure. J Gen Intern Med. 1989 Mar-Apr;4(2):101-7. — View Citation

Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Piña IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombo — View Citation

Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate trends of respiration rate per minute	Respiration rate measured by breaths taken per minute	6 months
Primary	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
Primary	Evaluate trends of temperature measured in Fahrenheit	Temperature	6 months
Primary	Evaluate trends of pulse rate per minute	Pulse rate	6 month
Primary	Evaluating the P wave of electrocardiogram in milliseconds	P wave on electrocardiogram will be measured to determine heart rhythm	6 months
Primary	Evaluating the QRS complex on electrocardiogram in milliseconds	QRS complex will be measured to determine heart rhythm	6 months
Primary	Evaluating the T wave on electrocardiogram in milliseconds	T wave will be measured to determine heart rhythm	6 months
Primary	Evaluate trends of blood pressure measured in mm/Hg	Blood pressure	6 months
Primary	Evaluate trends of blood oxygen saturation (SpO2) in percentage	blood oxygen saturation (SpO2)	6 months
Primary	Measuring FEV1 (Forced Expiratory Volume) in Liters	Determining Lung Function	6 months
Primary	Measuring FVC (Forced Vital Capacity) in Liters	Determining Lung Function	6 months
Primary	Measuring FEV1/FVC as a ratio	Determining Lung Function	6 months
Primary	Measuring PEF (Peak Expiratory Flow) in Liters/second	Determining Lung Function	6 months