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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04378179
• Other study ID #: 55057
• Status: Active, not recruiting
• Start date: December 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 205
• Est. completion date: December 31, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Francois Haddad	Precordior Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).