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

Completed

• Conditions: Pulmonary Hypertension; Heart Failure

• Registration Number: NCT04378179
• Lead Sponsor: Francois Haddad

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.

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-07
• Study Start: 2020-12-01
• Status Verified: 2022-06
• Primary Completion: 2022-10-07
• Study Completion: 2023-10-07
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart failure detection	Baseline to Day 2	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.

Secondary Outcome Measures

Name	Time	Method
Detection of differences in myocardial mechanics between admission and discharge	up to 2 weeks (during admission) and 2 to 14 weeks (during follow-up visit).	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States