NCT04112576

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

July 23, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

September 23, 2019

Last Update Submit

April 5, 2023

Conditions

Heart Failure, SystolicHeart Failure, Diastolic

Keywords

echocardiogram

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

HFrEF

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

Device: Wearable cardiac monitor

HFpEF

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

Device: Wearable cardiac monitor

Interventions

Wearable cardiac monitorDEVICE

Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

HFpEFHFrEF

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

National Heart Center Singapore

Singapore, 169609, Singapore

Location

MacKay Memorial Hospital

Taipei, 10449, Taiwan

Location

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Carolyn Lam, MD

    National Heart Center Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

October 2, 2019

Study Start

July 23, 2020

Primary Completion

May 11, 2022

Study Completion

May 11, 2022

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)US(1)SG(1)