Status:
COMPLETED
Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS)
Lead Sponsor:
Francois Haddad
Collaborating Sponsors:
Precordior Ltd
Conditions:
Heart Failure
Pulmonary Hypertension
Eligibility:
All Genders
21+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 7 2023
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04378179
Start Date
December 1 2020
End Date
October 7 2023
Last Update
December 2 2024
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94305