Clinical trial NCT04378179: Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS)
Official title: Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Pulmonary Hypertension
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Precordior Ltd
First posted: 2020-05-07
Enrollment: 205
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting Stanford Hospital and Clinics

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.

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

Primary outcomes:
measure: Heart failure detection
timeFrame: Baseline to Day 2
Secondary outcomes:
measure: Detection of differences in myocardial mechanics between admission and discharge
timeFrame: up to 2 weeks (during admission) and 2 to 14 weeks (during follow-up visit).
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Francois Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.