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

NCT ID: NCT04378179

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-10-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HFpEF

HF patients with preserved ejection fraction (HFpEF)

No interventions assigned to this group

HFrEF

HF patients with reduced ejection fraction (HFrEF)

No interventions assigned to this group

PH

Patients with Pulmonary hypertension (PH)

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Precordior Ltd

INDUSTRY

Sponsor Role collaborator

Francois Haddad

OTHER

Sponsor Role lead

Responsible Party

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Francois Haddad

Clinical Professor Medicine - Med/Cardiovascular Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Francois Haddad, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 38573263 (View on PubMed)

Other Identifiers

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55057

Identifier Type: -

Identifier Source: org_study_id