Heart FailureNCT04267744
Remote Monitoring of Multiple Indicators of Heart Failure
A study testing Myia Health® remote patient monitoring unblinded treatment arm in people with Heart Failure, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is intended to evaluate the impact of passive continuous remote patient monitoring to assist in the outpatient management of heart failure (HF) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Myia Health® remote patient monitoring unblinded treatment arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients cared for by BJH Advanced Heart Failure Clinic, where BJH is their primary cardiology care team
- Age ≥ 18 years old at time of consent
- HFrEF diagnosis in the BJH Advanced Heart Failure Clinic medical record
- Has had an ER presentation or hospitalization related to their heart failure in last 12 months prior to enrollment
- Most recent recorded Left Ventricular Ejection Fraction (LVEF) of < 50% and at least 1 recorded LVEF of < 40%
- Scheduled clinic visit 90- 180 days after study enrollment.
Show all 10Show fewer
- NYHA Class II-IV
- Sleeps in the same bed at ≥ 4 days per week
- Able to ambulate
- Willingness to complete the required surveys, measurements and study activities
Who cannot join
- Current ventricular assist device or cardiac transplant.
- Currently listed for cardiac transplantation
- End-Stage Renal Disease on chronic dialysis
- Malignancy diagnosis undergoing active treatment
- Hospice or palliative care
- Living in a skilled nursing facility or other chronic care facility (ambulatory patients only)
Show all 12Show fewer
- Self-reported pregnancy or planned pregnancy in the next 6 months
- Inability or unwillingness to consent and/or follow requirements of the study
- Planned major surgeries or procedures requiring hospitalization in next 6 months
- Use of Lifevest or other worn device that may affect ballistocardiogram measurements
- Patient weight > 385 lbs at time of enrollment
- Life expectancy <1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Usability and Utility Assessment of Passive Remote Monitoring of Multiple Novel Indicators of Heart Failure
This study is intended to evaluate the impact of passive continuous remote patient monitoring to assist in the outpatient management of heart failure (HF) patients.
Read the detailed description
The study will prospectively evaluate the usability, utility, and efficacy of remote monitoring using novel noninvasive technologies in HF patients in an outpatient setting. Investigators will gather dynamic, longitudinal data from multiple sensors, in addition to patient-reported and physician-reported data. Both the patient interface through interactions with the sensors and mobile application, and the clinician interface through the monitoring portal, will be evaluated for usability, utility and efficacy.
Patients will be recruited for the study from the Barnes Jewish Hospital Advanced Heart Failure Clinic. Eligible individuals will receive onboarding instructions and a study schedule detailing the required surveys and clinical activities they will be asked to complete over a period of 7 months. In addition to onboarding instructions and a study schedule, individuals will have the kit of sensors shipped to their home.
After the Myia Home Hub and Myia Sensor Suite are set up, data will begin to be transmitted. Following a run in period where data is collected and delivered but not acted upon by clinicians all eligible participants will move forward with 6 month interactive study monitoring.
In addition to obtaining questionnaires and using the devices in the Myia kit, participants will also be asked to obtain their blood pressure and weight daily.
During the course of the study, outpatient health status data for the group will be collected, summarized and delivered to clinicians in an electronic dashboard. The format and content of the data dashboard will be updated based on user feedback throughout the study. Required changes deemed appropriate by the healthcare team will be incorporated into the software platform alongside any standard updates.
- Conditions
- Heart Failure
- Being tested
- Myia Health® remote patient monitoring unblinded treatment arm
- Keywords
- NYHA II-IV, Reduced Ejection Fraction, Cardiology
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myia Health® remote patient monitoring unblinded treatment armOther
Also called Myia Health platform and in-home suite of devices®
After consenting to the study, the Myia in-home suite of devices will be provided to all recruited patients. The data flowing from the Myia platform will be available to clinicians and patients for the duration of the pilot and utilized to complete study activities.
Device: Myia Health platform and in-home suite of devices®:
Emfit Ballistocardiograph® Withings Connected Scale® VitalScout (VivaLink) ECG Accelerometer® Omron Blood Pressure Monitor® (Sphygmomanometer) Cradlepoint - Hotspot / Adaptor® (LTE Connection) Samsung Galaxy Tab A 8.0"® (User Interface)
| Study group | Role | What they receive |
|---|---|---|
| Remote patient monitoring | Other | After consenting to the study, the Myia in-home suite of devices, and mobile phone application if the patient owns a smart phone, will be provided to all recruited patients. The data flowing from the Myia platform will be available to clinicians and patients for the duration of the pilot and utilized to complete study activities.
Patients enrolled will transmit daily vital sign data to the Myia Health remote patient monitoring platforms for clinical review.
Enrolled patients will complete medication change/compliance survey monthly to assess for medication changes.
Enrolled patients will complete symptomatic assessments (KCCQ-12) at 0, 3, and 6 months.
Enrolled patients will complete a Check-In survey to assess utility and usability of the intervention at the 2, 4, and 6 month timepoints Receives: Other: Myia Health® remote patient monitoring unblinded treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myia Platform feasibility: questionnaire
Patient perception of the Myia Platform will be assessed during the study using a structured questionnaire, delivered either electronically or by paper to patients by research staff.
Patient Platform satisfaction/usability/utility questionnaire: The formal title of the questionnaire is 'Check In Survey' and it consists of 17 questions with scaled options, 1-7 (1=most positive, 7=most negative) and it is administered at 3 time points. The lower the overall total the more positive the patient rating of the Myia Platform.
Measured: From baseline to 6 months (final)
Secondary outcomes (8)
Persistence of minimally useful data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Acquisition of minimally useful data profile: Weeks where minimally useful data profile collected/total number of weeks. This endpoint will be defined retrospectively by the clinical team.
Measured: From baseline to 6 months time (final)
Persistence of daily data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Acquisition of any data point daily: Days with >1 data point collected/total number of days
Measured: From baseline to 6 months time (final)
Persistence of weekly data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Acquisition of any data point weekly: Weeks with >1 data point collected/total number of weeks
Measured: From baseline to 6 months time (final)
Persistence of vital sign data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Acquisition of continuous vital sign data variables daily: Days with >1 data point collected/total number of days
Measured: From baseline to 6 months time (final)
Persistence of greater than 1 data point per week data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Acquisition of continuous data variables weekly: Weeks with >1 data point collected/total number of weeks
Measured: From baseline to 6 months time (final)
Medication management: total number of medication changes
Absolute count of heart failure medication changes per patient. This metric will be calculated on a per patient level. Any change in dose or frequency of medication will be considered a medication change.
Measured: From baseline to 6 months time (final)
Medication management: length of time to medication change
Mean time to heart failure medication change per patient. Average time interval between a change to 1 or more heart failure drugs between the baseline and 6 month time points.
Measured: From baseline to 6 months time (final)
Medication management: target dose
Distance from target dose of heart failure medication (< 50% target dose, 50%-75% of target dose, 75%-100% of target dose)
The baseline use and dose of the following heart failure medication categories will be examined for each patient at baseline:
Beta Blockers Digoxin ACE, ARB, ARNIs Hydralazine Nitrates Loop Diuretics Aldosterone Antagonists For each medication class, the presence and absence of absolute contraindications will be determined based on documentation in the medical record or as ascertained by study investigators. For each patient and each medication, available dose information will be reviewed in reference to recommended target doses by clinical practice guidelines. Distance to target dose will be assessed at baseline and follow-up. The difference in the relative proportion of people in the target dose categories will be compared between treatment and usual care groups.
Measured: From baseline to 6 months time (final)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start11 Feb 2020
- Primary completion31 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device: Myia Health platform and in-home suite of devices®
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Healthcare Innovation Lab, MYIA Labs, Inc.
- Responsible party
- Sponsor
- Investigators
- Greg Ewald, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267744
- Sponsor's protocol ID
- 201908180
- Status last verified
- Dec 2023
- First submitted
- 5 Feb 2020
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
PubMed 29386200Chen J, Normand SL, Wang Y, Krumholz HM. National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries, 1998-2008. JAMA. 2011 Oct 19;306(15):1669-78. doi: 10.1001/jama.2011.1474.
PubMed 22009099Wolfel EE. Can we predict and prevent the onset of acute decompensated heart failure? Circulation. 2007 Oct 2;116(14):1526-9. doi: 10.1161/CIRCULATIONAHA.107.729608. No abstract available.
PubMed 17909113Ping W, Jin-Gang W, Xiao-Bo S, Wei H. The research of telemedicine system based on embedded computer. Conf Proc IEEE Eng Med Biol Soc. 2005;2006:114-7. doi: 10.1109/IEMBS.2005.1616355.
PubMed 17282124Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.
PubMed 21315441Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.
PubMed 28254128Weng SF, Reps J, Kai J, Garibaldi JM, Qureshi N. Can machine-learning improve cardiovascular risk prediction using routine clinical data? PLoS One. 2017 Apr 4;12(4):e0174944. doi: 10.1371/journal.pone.0174944. eCollection 2017.
PubMed 28376093Chan PS, Oetgen WJ, Spertus JA. The Improving Continuous Cardiac Care (IC(3)) program and outpatient quality improvement. Am J Med. 2010 Mar;123(3):217-9. doi: 10.1016/j.amjmed.2009.09.019. No abstract available.
PubMed 20193826Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.
PubMed 26857383Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.
PubMed 20031870Chun S, Tu JV, Wijeysundera HC, Austin PC, Wang X, Levy D, Lee DS. Lifetime analysis of hospitalizations and survival of patients newly admitted with heart failure. Circ Heart Fail. 2012 Jul 1;5(4):414-21. doi: 10.1161/CIRCHEARTFAILURE.111.964791. Epub 2012 May 2.
PubMed 22556322Tung YC, Chou SH, Liu KL, Hsieh IC, Wu LS, Lin CP, Wen MS, Chu PH. Worse Prognosis in Heart Failure Patients with 30-Day Readmission. Acta Cardiol Sin. 2016 Nov;32(6):698-707. doi: 10.6515/acs20151113a.
PubMed 27899857Sud M, Yu B, Wijeysundera HC, Austin PC, Ko DT, Braga J, Cram P, Spertus JA, Domanski M, Lee DS. Associations Between Short or Long Length of Stay and 30-Day Readmission and Mortality in Hospitalized Patients With Heart Failure. JACC Heart Fail. 2017 Aug;5(8):578-588. doi: 10.1016/j.jchf.2017.03.012. Epub 2017 May 10.
PubMed 28501521Holland R, Rechel B, Stepien K, Harvey I, Brooksby I. Patients' self-assessed functional status in heart failure by New York Heart Association class: a prognostic predictor of hospitalizations, quality of life and death. J Card Fail. 2010 Feb;16(2):150-6. doi: 10.1016/j.cardfail.2009.08.010. Epub 2009 Oct 22.
PubMed 20142027Soto GE, Jones P, Weintraub WS, Krumholz HM, Spertus JA. Prognostic value of health status in patients with heart failure after acute myocardial infarction. Circulation. 2004 Aug 3;110(5):546-51. doi: 10.1161/01.CIR.0000136991.85540.A9. Epub 2004 Jul 19.
PubMed 15262843
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Utility Assessment of Passive Remote Monitoring of Multiple Novel Indicators of Heart Failure
- ClinicalTrials.gov ID
- NCT04267744
- Acronym / sponsor ID
- 201908180
- Conditions
- Heart Failure
- Keywords
- NYHA II-IV, Reduced Ejection Fraction, Cardiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Healthcare Innovation Lab, MYIA Labs, Inc.
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to evaluate the impact of passive continuous remote patient monitoring to assist in the outpatient management of heart failure (HF) patients.
Detailed description
The study will prospectively evaluate the usability, utility, and efficacy of remote monitoring using novel noninvasive technologies in HF patients in an outpatient setting. Investigators will gather dynamic, longitudinal data from multiple sensors, in addition to patient-reported and physician-reported data. Both the patient interface through interactions with the sensors and mobile application, and the clinician interface through the monitoring portal, will be evaluated for usability, utility and efficacy.
Patients will be recruited for the study from the Barnes Jewish Hospital Advanced Heart Failure Clinic. Eligible individuals will receive onboarding instructions and a study schedule detailing the required surveys and clinical activities they will be asked to complete over a period of 7 months. In addition to onboarding instructions and a study schedule, individuals will have the kit of sensors shipped to their home.
After the Myia Home Hub and Myia Sensor Suite are set up, data will begin to be transmitted. Following a run in period where data is collected and delivered but not acted upon by clinicians all eligible participants will move forward with 6 month interactive study monitoring.
In addition to obtaining questionnaires and using the devices in the Myia kit, participants will also be asked to obtain their blood pressure and weight daily.
During the course of the study, outpatient health status data for the group will be collected, summarized and delivered to clinicians in an electronic dashboard. The format and content of the data dashboard will be updated based on user feedback throughout the study. Required changes deemed appropriate by the healthcare team will be incorporated into the software platform alongside any standard updates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device: Myia Health platform and in-home suite of devices®
| Arm | Type | Receives |
|---|---|---|
| Remote patient monitoring | Other | Other: Myia Health® remote patient monitoring unblinded treatment armAfter consenting to the study, the Myia in-home suite of devices, and mobile phone application if the patient owns a smart phone, will be provided to all recruited patients. The data flowing from the Myia platform will be available to clinicians and patients for the duration of the pilot and utilized to complete study activities. Patients enrolled will transmit daily vital sign data to the Myia Health remote patient monitoring platforms for clinical review. Enrolled patients will complete medication change/compliance survey monthly to assess for medication changes. Enrolled patients will complete symptomatic assessments (KCCQ-12) at 0, 3, and 6 months. Enrolled patients will complete a Check-In survey to assess utility and usability of the intervention at the 2, 4, and 6 month timepoints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Outpatients cared for by BJH Advanced Heart Failure Clinic, where BJH is their primary cardiology care team
- Age ≥ 18 years old at time of consent
- HFrEF diagnosis in the BJH Advanced Heart Failure Clinic medical record
- Has had an ER presentation or hospitalization related to their heart failure in last 12 months prior to enrollment
- Most recent recorded Left Ventricular Ejection Fraction (LVEF) of < 50% and at least 1 recorded LVEF of < 40%
Key exclusion criteria (12 listed)
- Current ventricular assist device or cardiac transplant.
- Currently listed for cardiac transplantation
- End-Stage Renal Disease on chronic dialysis
- Malignancy diagnosis undergoing active treatment
- Hospice or palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myia Health® remote patient monitoring unblinded treatment armAlso: Myia Health platform and in-home suite of devices®After consenting to the study, the Myia in-home suite of devices will be provided to all recruited patients. The data flowing from the Myia platform will be available to clinicians and patients for the duration of the pilot and utilized to complete study activities. Device: Myia Health platform and in-home suite of devices®: Emfit Ballistocardiograph® Withings Connected Scale® VitalScout (VivaLink) ECG Accelerometer® Omron Blood Pressure Monitor® (Sphygmomanometer) Cradlepoint - Hotspot / Adaptor® (LTE Connection) Samsung Galaxy Tab A 8.0"® (User Interface) | Other | Remote patient monitoring |
Primary outcome
Myia Platform feasibility: questionnaire
Time frame: From baseline to 6 months (final)
Patient perception of the Myia Platform will be assessed during the study using a structured questionnaire, delivered either electronically or by paper to patients by research staff. Patient Platform satisfaction/usability/utility questionnaire: The formal title of the questionnaire is 'Check In Survey' and it consists of 17 questions with scaled options, 1-7 (1=most positive, 7=most negative) and it is administered at 3 time points. The lower the overall total the more positive the patient rating of the Myia Platform.
8 secondary outcomes
Persistence of minimally useful data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Time frame: From baseline to 6 months time (final)
Persistence of daily data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Time frame: From baseline to 6 months time (final)
Persistence of weekly data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Time frame: From baseline to 6 months time (final)
Persistence of vital sign data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Time frame: From baseline to 6 months time (final)
Persistence of greater than 1 data point per week data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
Time frame: From baseline to 6 months time (final)
Medication management: total number of medication changes
Time frame: From baseline to 6 months time (final)
Medication management: length of time to medication change
Time frame: From baseline to 6 months time (final)
Medication management: target dose
Time frame: From baseline to 6 months time (final)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 29386200Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
- Background: PubMed 22009099Chen J, Normand SL, Wang Y, Krumholz HM. National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries, 1998-2008. JAMA. 2011 Oct 19;306(15):1669-78. doi: 10.1001/jama.2011.1474.
- Background: PubMed 17909113Wolfel EE. Can we predict and prevent the onset of acute decompensated heart failure? Circulation. 2007 Oct 2;116(14):1526-9. doi: 10.1161/CIRCULATIONAHA.107.729608. No abstract available.
- Background: PubMed 17282124Ping W, Jin-Gang W, Xiao-Bo S, Wei H. The research of telemedicine system based on embedded computer. Conf Proc IEEE Eng Med Biol Soc. 2005;2006:114-7. doi: 10.1109/IEMBS.2005.1616355.
- Background: PubMed 21315441Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.
- Background: PubMed 28254128Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.
- Background: PubMed 28376093Weng SF, Reps J, Kai J, Garibaldi JM, Qureshi N. Can machine-learning improve cardiovascular risk prediction using routine clinical data? PLoS One. 2017 Apr 4;12(4):e0174944. doi: 10.1371/journal.pone.0174944. eCollection 2017.
- Background: PubMed 20193826Chan PS, Oetgen WJ, Spertus JA. The Improving Continuous Cardiac Care (IC(3)) program and outpatient quality improvement. Am J Med. 2010 Mar;123(3):217-9. doi: 10.1016/j.amjmed.2009.09.019. No abstract available.
- Background: PubMed 26857383Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.
- Background: PubMed 20031870Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.
- Background: PubMed 22556322Chun S, Tu JV, Wijeysundera HC, Austin PC, Wang X, Levy D, Lee DS. Lifetime analysis of hospitalizations and survival of patients newly admitted with heart failure. Circ Heart Fail. 2012 Jul 1;5(4):414-21. doi: 10.1161/CIRCHEARTFAILURE.111.964791. Epub 2012 May 2.
- Background: PubMed 27899857Tung YC, Chou SH, Liu KL, Hsieh IC, Wu LS, Lin CP, Wen MS, Chu PH. Worse Prognosis in Heart Failure Patients with 30-Day Readmission. Acta Cardiol Sin. 2016 Nov;32(6):698-707. doi: 10.6515/acs20151113a.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Ewald, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myia Health® remote patient monitoring unblinded treatment arm in people with Heart Failure, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myia Platform feasibility: questionnaire (time frame: From baseline to 6 months (final)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267744, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.