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OpenTrials
Completed

NCT Number: NCT04378179

Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS)

The study will test the ability a novel wearable sensor based on a smartphone app (Precordior CardioSignal app) in combination with a sensor device (Suunto Movesense sensor) to non-invasively measure cardiac motion and function.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Palo Alto, California, 94305, United States

About this study

Heart Failure (HF) is a syndrome where the heart is unable to pump or fill adequately to meet the circulatory needs of the body. The main purpose of this study is to test the ability a novel wearable sensor based on a smartphone app (Precordior CardioSignal app) in combination with a sensor device (Suunto Movesense sensor) to non-invasively measure cardiac motion and function. The phone and sensor are positioned on the chest and echocardiography is used as a gold standard to assess cardiac mechanics including myocardial strain, cardiac torsion, diastolic filling characteristics, hemodynamics including pressure estimates and stroke volume.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 21 years
  • Able to consent in English and follow study instructions
  • Patients hospitalized or being seen in clinic with heart failure with a diagnosis of HFpEF, HFrEF or PH, as corresponding to each target patient group
  • Control patients may include patients that are hospitalized without heart failure, and cardiology patients without heart failure who are seen in outpatient cardiology, who may have suspected CAD and are scheduled for CCTA.

Exclusion criteria

  • Severe cardiac valvular heart disease
  • Previous prosthetic cardiac valve
  • Pericardial disease including constrictive pericarditis or moderate or large pericardial effusion
  • Mechanical circulatory support (including ECMO, LVADs etc).
  • Heart and/or lung transplant recipients
  • Major adverse cardiovascular event or surgery within 6 weeks of planned study enrollment
  • Patients with pacemaker that has over 1% of beats paced
  • Pectus excavatum (severe)
  • Pregnant women
  • On Dialysis
  • Exclude at the clinical discretion of the Principal Investigators
  • Not possible to acquire echocardiography with sufficient quality

Treatment and study plan

Primary outcomes

  1. Heart failure detection

    Time frame: Baseline to Day 2

    Test the ability of the Precordior sensor to detect heart failure with reduced ejection fraction, heart failure with preserved ejection fraction and pulmonary hypertension compared to control participants. An additional comparison will be made to individuals without signs, diagnosed, or suspected HF who will be undergoing CCTA due to suspected CAD.

Secondary outcomes

  1. Detection of differences in myocardial mechanics between admission and discharge

    Time frame: up to 2 weeks (during admission) and 2 to 14 weeks (during follow-up visit).

    The ability of the Precordior sensor to detect differences in myocardial mechanics as defined my myocardial longitudinal strain, hemodynamics and torsion analysis from admission and discharge.

Sponsors and collaborators

Lead sponsor

Francois Haddad

Other

Collaborators

  • Precordior Ltd

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 7, 2020
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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