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CompletedNCT04378179Updated Dec 2, 2024

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

An observational study in Heart Failure and Pulmonary Hypertension, sponsored by Francois Haddad. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Francois Haddad · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
205
Ages
21 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Heart Failure
  • Pulmonary Hypertension
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 205 is above the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

This is the only study on the registry with Francois Haddad as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients visiting Stanford Hospital and Clinics

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
205 participants (actual)
Patient registry
No

Groups and cohorts

  • HFpEF

    HF patients with preserved ejection fraction (HFpEF)

  • HFrEF

    HF patients with reduced ejection fraction (HFrEF)

  • PH

    Patients with Pulmonary hypertension (PH)

  • Control

    Elective patients visiting hospital cardiology who are not diagnosed with either HFpEF or HFrHF or PH but meet other inclusion criteria and none of the exclusion criteria.

  • Controls with suspected CAD

    Elective patients visiting hospital cardiology who are not diagnosed with either HFpEF or HFrHF or PH but meet other inclusion criteria and none of the exclusion criteria, and may have a diagnosis of Coronary Artery Disease (CAD) or may be suspected to have CAD.

06

What researchers measure

Primary outcomes

  1. Heart failure detection

    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.

    Time frame: Baseline to Day 2

Secondary outcomes

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

    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.

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

07

Study locations

1 site
  • Stanford University
    Palo Alto, California 94305, United States
08

References and documents

Publications

  • Haddad F, Saraste A, Santalahti KM, Pankaala M, Kaisti M, Kandolin R, Simonen P, Nammas W, Jafarian Dehkordi K, Koivisto T, Knuuti J, Mahaffey KW, Blomster JI. Smartphone-Based Recognition of Heart Failure by Means of Microelectromechanical Sensors. JACC Heart Fail. 2024 Jun;12(6):1030-1040. doi: 10.1016/j.jchf.2024.01.022. Epub 2024 Apr 3. PubMed 38573263 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04378179
Lead sponsor
Francois Haddad
Collaborators
Precordior Ltd
Responsible party
Francois Haddad (Clinical Professor Medicine - Med/Cardiovascular Medicine, Stanford University) — Sponsor-investigator
First posted
May 7, 2020
Start date
Dec 1, 2020
Primary completion
Oct 7, 2022
Completion
Oct 7, 2023
Last update
Dec 2, 2024

Study contacts

Francois Haddad, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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