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

Francois Haddad

Status: Completed

Conditions: Heart Failure; Pulmonary Hypertension

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04378179

55057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

205 participants in 5 patient groups

HFpEF

Description:

HF patients with preserved ejection fraction (HFpEF)

HFrEF

Description:

HF patients with reduced ejection fraction (HFrEF)

PH

Description:

Patients with Pulmonary hypertension (PH)

Control

Description:

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

Description:

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.