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

NCT04378179 | Completed

• 1 other identifier: 55057
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (5)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting Stanford Hospital and Clinics

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Francois Haddad: lead
• Precordior Ltd: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 38573263 RESULT

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Francois Haddad, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor Medicine - Med/Cardiovascular Medicine

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: December 1, 2020
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2023
• Last Updated: December 2, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)