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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04378179
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Francois Haddad
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Francois Haddad, MD
Principal Investigator Affiliation	Stanford University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Heart Failure, Pulmonary Hypertension

Additional Details

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.

Arms & Interventions

Arms

: HFpEF

HF patients with preserved ejection fraction (HFpEF)

: HFrEF

HF patients with reduced ejection fraction (HFrEF)

: PH

Patients with Pulmonary hypertension (PH)

: Control

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

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.

Interventions

Contact a Trial Team

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Stanford University, Palo Alto, California

Status

Address

Stanford University

Palo Alto, California, 94305

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