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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Pulmonary Hypertension

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.

• Study Type: Observational
• Enrollment (Actual): 205

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients visiting Stanford Hospital and Clinics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 weeks (during admission) and 2 to 14 weeks (during follow-up visit).

Collaborators and Investigators

• Sponsor: Francois Haddad
• Collaborators: Precordior Ltd
• Investigators: Principal Investigator: Francois Haddad, MD, Stanford University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): October 7, 2023

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Heart Failure; Hypertension, Pulmonary
• Other Study ID Numbers: 55057

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
• product manufactured in and exported from the U.S.: No