Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study (HAPI-HF)

To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF).

To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function

Study Overview

• Status: Completed
• Conditions: Heart Failure, Diastolic; Heart Failure, Systolic
• Intervention / Treatment: Device: Wearable cardiac monitor

Detailed Description

This is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with HFpEF or HFrEF. Approximately 70% of participants will have HFpEF and 30% will have HFrEF.

There will be one study visit per participant. The study visit includes device placement and data collection during postural changes. Echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. The device will then be removed.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169609
    • National Heart Center Singapore
• Taiwan
  • Taipei City, Taiwan, 10449
    • Mackay Memorial Hospital
• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that are diagnosed with NYHA class II or III heart failure with preserved or reduced ejection fraction.

Description

Inclusion Criteria:

• Patients with NYHA class II or III heart failure defined by symptoms and signs of heart failure
• Documented episode of decompensated heart failure in the past 3 years, which either: a) resulted in a hospital admission (primary diagnosis) or b) was treated in out-patient clinic
• HFrEF defined by documented evidence of EF ≤ 40% OR
• HFpEF defined by documented evidence of:
• EF ≥ 50% and no prior record of EF < 40%
• Evidence of relevant structural heart disease or diastolic dysfunction on echocardiographic as defined in the 2016 ESC guidelines
• Able to understand and willing to provide written informed consent to participate in the trial
• Age 21 years old or greater
• Willing and able to participate in the required testing

Exclusion Criteria:

• Prior hospitalization, CV event or surgery within 6 weeks
• Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system or include the usage of investigational drugs.
• Patients with Active Implantable Medical Devices
• Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
• Have a prosthetic cardiac valve, previously underwent cardiac valve surgery or have hemodynamically unstable (as judged by local investigator) valvular disease
• Subject is pregnant as indicated by patient record
• Patients with rash or open wound on torso locations where investigational devices will be placed
• Patient deemed as clinically unstable or unsuitable to perform prescribed testing as judged by the local investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HFrEF; Participants that are diagnosed with NYHA class II or III heart failure with reduced ejection fraction.	Device: Wearable cardiac monitor; Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.
HFpEF; Participants that are diagnosed with NYHA class II or III heart failure with preserved ejection fraction.	Device: Wearable cardiac monitor; Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiologic Signal Detection	Characterize differences in cardiac physiology and dynamics between heart failure with preserved ejection fraction and heart failure with reduced ejection fraction patient populations using a wearable cardiac monitor prototype device.	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Carolyn Lam, MD, National Heart Center Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: echocardiogram
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic
• Other Study ID Numbers: C2116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No