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

NCT04191356 | Terminated

• 1 other identifier: CT003
• Study Type: observational
• Target: 67
• Locations: 2 countries
• Sites: 6

Brief 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. 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. 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

Outcome Measures

Primary Outcomes (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

  8 weeks

Secondary Outcomes (4)

• Compliance rate

  8 weeks

• Drop-out rate

  8 weeks

• Mean time worn/day

  8 weeks

• Proportion of time worn that device produces reliable data

  8 weeks

Other Outcomes (5)

• Percentage of patients on HF GDMT

  8 weeks

• Percentage of patients on target dose of HF GDMT

  8 weeks

• Unplanned hospital visits of patients on HF GDMT and target dose of GDMT

  8 weeks

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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
• \. Currently receiving treatment or procedure in another investigational device or drug study.
• 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).

Sponsors & Collaborators

• Biofourmis Singapore Pte Ltd.: lead
• Food and Drug Administration (FDA): collaborator
• Mayo Clinic: collaborator

Study Sites (6)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Related Publications (4)

• 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.

  PMID: 23141494 BACKGROUND

• 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.

  PMID: 27756791 BACKGROUND

• 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.

  PMID: 25488549 BACKGROUND

• 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.

  PMID: 9699234 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Maulik Majmudar, M.D.

  Biofourmis Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 9, 2019
• Study Start: October 17, 2020
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); SG (5)