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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Heart Failure, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HFpEF<br>HF patients with preserved ejection fraction (HFpEF) | |
| HFrEF<br>HF patients with reduced ejection fraction (HFrEF) | |
| PH<br>Patients with Pulmonary hypertension (PH) | |
| Control<br>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<br>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). |