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

NCT04757246 | Withdrawn

• 1 other identifier: 1705978
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (3)

Cohort 1

OTHER

Stable outpatients without implantable devices

Other: MouthLab Device

Cohort 2

OTHER

Stable outpatients with Boston Scientific pacemakers or defibrillators with Heart Logic capability

Other: MouthLab Device

Cohort 3

OTHER

Stable outpatients with implantable CardioMEMS devices

Other: MouthLab Device

Interventions

MouthLab Device OTHER

Use of MouthLab system

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Patients currently on inotropes
• English speaking
• Currently on dialysis
• Currently on hospice
• Have a heart transplant or left ventricular assist device

Sponsors & Collaborators

• WakeMed Health and Hospitals: lead

Study Sites (1)

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610, United States

Location

Related 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, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.

  PMID: 30700139 RESULT

• Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.

  PMID: 26673558 RESULT

• Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.

  PMID: 23616602 RESULT

• 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.

  PMID: 32164892 RESULT

• 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. doi: 10.1007/BF02602348.

  PMID: 2709167 RESULT

• Garin O, Ferrer M, Pont A, Rue 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/s11136-008-9416-4. Epub 2008 Dec 4.

  PMID: 19052916 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 17, 2021
• Study Start: October 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 20, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)