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Heart FailureNCT04191356

Evaluating Mobile Health Tool Use for Capturing Patient-centered Outcomes Measures in HF Patients

An observational study of Heart Failure, run by Biofourmis Singapore Pte Ltd. at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Heart Failure
How many people
67 participants
Where
6 sitesin 2 countries
Study dates
17 Oct 2020to 6 Feb 2023
Phase
Observational
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 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Approximately 150 eligible subjects will be enrolled into the study. Eligible subjects will include adults with a diagnosis of heart failure (NYHA class I to class III), and screened within 30 days after Clinic Visit or hospitalization for heart failure - either as a primary or secondary diagnosis.

Who may be able to join

  • Subjects are eligible to be included in the study only if all the following criteria apply:
  • Subjects has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age more than 21 to less than 85 years at signing of informed consent.
  • Diagnosis of heart failure, defined as requiring pharmacologic treatment for heart failure, with NYHA class I to class III at most recent screening assessment
  • Screening within 30 days after Clinic Visit or hospitalization for heart failure - either as a primary or secondary diagnosis.
  • History of (within the past 6 months) or current use of diuretics.
  • HF patient who is willing to comply with study restrictions including Everion device management (wearing and charging the device), Apple watch Series 4 and above device management (wearing and charging the device) and BiovitalsHF Patient App Management (pairing Everion device and Apple watch Series 4 and above and BiovitalsHF Patient App, and carrying the smartphone for answering questionnaires and data reporting)

Who cannot join

  • Subjects are excluded from the study if any of the following criteria apply:
  • Disease Related
  • Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina) stroke, or transient ischemic attack, major cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 30 days prior to screening.
  • Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) more than or equal to 180 mm Hg or diastolic BP (DBP)more than or equal to 110 mm Hg.
  • Untreated severe ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation).
  • Symptomatic bradycardia or second or third-degree heart block without a pacemaker
Show all 20Show fewer
  • Other Medical Conditions
  • Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
  • Hospitalization with any pathology that may meaningfully interfere with functional tolerance, cardiopulmonary capacity or mobility within the 30 days prior to screening.
  • Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 or receiving dialysis at screening.
  • Prior/Concomitant Medication
  • 1. Currently receiving treatment or procedure in another investigational device or drug study.
  • Other Exclusions
  • Likely to receive during the duration of the study, in the opinion of the investigator, planned revascularization, implantation of ICD or CRT, ventricular assist device, continuous or intermittent inotropic therapy, hospice care, or cardiac transplant.
  • Implantable cardioverter defibrillator or initiation of cardiac resynchronization therapy (CRT) (with/without implantable cardioverter defibrillator) within 30 days prior to enrollment.
  • Recipient of any major organ transplant (e.g. lung, liver, heart, bone marrow, kidney).
  • Less than 4 months prior Interventional Clinical Study participation.
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g. Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  • Any individuals that are lacking the ability to consent.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Singapore5 sites

  • National University Hospital

    Singapore, 119074

  • National Heart Centre Singapore

    Singapore, 169609

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Changi General Hospital

    Singapore, 529889

  • Khoo Teck Puat Hospital

    Singapore, 768828

Other trials in Singapore

United States1 site

  • Mayo Clinic

    Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: An Observational, Multicentre Study to Evaluate the Feasibility of a Novel Mobile Health Monitoring Platform to Capture Patient-centered Outcomes Measures Among Patients With Heart Failure (HF)

Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations.

Although functional status can be objectively measured by peak exercise oxygen consumption, it is difficult and impractical to implement in large clinical studies, especially in an ambulatory real-world setting. Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms.

Read more

The goal of this observational study is to evaluate the feasibility of monitoring functional capacity among patients with heart failure (HF) using mobile health monitoring platforms.

Everion® and Apple Watch Series 4 and above will be used for this study. The BiovitalsHF® mobile app can capture patients' key cardiopulmonary physiological parameters, functional capacity (using activity patterns, including guided mobile-based 6MWT, audio recording) and assessment of QoL through validated PROs.

Conditions
Heart Failure
Keywords
6MWT, accelerometer, biosensors, wearable
Medical subject headings
Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of monitoring functional capacity among patients using mobile health monitoring platform

    Measurement of correlation between physiology and accelerometer (activity) data/derivatives with:

    • 6MWT
    • Patient-reported KCCQ
    • Lab results

    Measured: 8 weeks

Secondary outcomes (4)

  1. Compliance rate

    Compliance rate to measure the feasibility of collecting continuous, biometrics data and ePROs using mobile-health monitoring platform

    Measured: 8 weeks

  2. Drop-out rate

    Drop-out rate to measure the feasibility of collecting continuous, biometrics data and ePROs using mobile-health monitoring platform

    Measured: 8 weeks

  3. Mean time worn/day

    Mean time worn/day to measure the feasibility of collecting continuous, biometrics data and ePROs using mobile-health monitoring platform

    Measured: 8 weeks

  4. Proportion of time worn that device produces reliable data

    Proportion of time worn that device produces reliable data to measure the feasibility of collecting continuous, biometrics data and ePROs using mobile-health monitoring platform

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start17 Oct 2020
  3. Primary completion6 Feb 2023
  4. Study completion6 Feb 2023

Why it stopped: Collected enough data to support the Endpoints

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04191356
Sponsor's protocol ID
CT003
Status last verified
Oct 2023
First submitted
26 Nov 2019
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Campbell RT, Jhund PS, Castagno D, Hawkins NM, Petrie MC, McMurray JJ. What have we learned about patients with heart failure and preserved ejection fraction from DIG-PEF, CHARM-preserved, and I-PRESERVE? J Am Coll Cardiol. 2012 Dec 11;60(23):2349-56. doi: 10.1016/j.jacc.2012.04.064. Epub 2012 Nov 7.

    PubMed 23141494

  • Butler J, Hamo CE, Udelson JE, Pitt B, Yancy C, Shah SJ, Desvigne-Nickens P, Bernstein HS, Clark RL, Depre C, Dinh W, Hamer A, Kay-Mugford P, Kramer F, Lefkowitz M, Lewis K, Maya J, Maybaum S, Patel MJ, Pollack PS, Roessig L, Rotman S, Salsali A, Sims JJ, Senni M, Rosano G, Dunnmon P, Stockbridge N, Anker SD, Zile MR, Gheorghiade M. Exploring New Endpoints for Patients With Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Nov;9(11):e003358. doi: 10.1161/CIRCHEARTFAILURE.116.003358.

    PubMed 27756791

  • Palau P, Nunez E, Dominguez E, Sanchis J, Nunez J. Physical therapy in heart failure with preserved ejection fraction: A systematic review. Eur J Prev Cardiol. 2016 Jan;23(1):4-13. doi: 10.1177/2047487314562740. Epub 2014 Dec 8.

    PubMed 25488549

  • Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998 Jul 30;17(14):1623-34. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-s.

    PubMed 9699234

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Biofourmis Singapore Pte Ltd. at 6 sites in 2 countries.

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 7 inclusion and 20 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: stopped early, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Singapore, 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?

The study was stopped early (reason given: Collected enough data to support the Endpoints). 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?

Feasibility of monitoring functional capacity among patients using mobile health monitoring platform (time frame: 8 weeks). 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 NCT04191356, which also lists 4 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 5 Oct 2023.

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