Clinical Evaluation of Cordio App in Adult ADHF Patients

NCT ID: NCT03266029

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-24

Study Completion Date

2020-12-10

Brief Summary

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Observational study on ADHF patients at one site in Israel. After signing informed consent and undergoing screening assessments, eligible patients will record sentences into a smartphone. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital: admittion, release. Before hospital release, if applicable and upon patient agrreement, an app will be installed in a smartphone in order to continue the recording at home.

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cordio App

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ADHF (pulmonary congestion)
* Known diagnosis of HF, with either preserved or reduced LVEF.
* 18+ years old.
* Able to understand and provide written informed consent.

Exclusion Criteria

* Subjects unable to comply with the daily use of the application due to mental disorders.
* GFR \<25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis.
* Subjects with congenital heart disease or mechanical right heart valve(s).
* Airway and lung infection and Sepsis
* Patients with severe alcohol or drug use.
* Women who are pregnant or lactating.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordio Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zaher Azzam, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Facility

Locations

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Rambam Health Care Facility

Haifa, , Israel

Site Status

Countries

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Israel

References

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Amir O, Abraham WT, Azzam ZS, Berger G, Anker SD, Pinney SP, Burkhoff D, Shallom ID, Lotan C, Edelman ER. Remote Speech Analysis in the Evaluation of Hospitalized Patients With Acute Decompensated Heart Failure. JACC Heart Fail. 2022 Jan;10(1):41-49. doi: 10.1016/j.jchf.2021.08.008. Epub 2021 Dec 8.

Reference Type DERIVED
PMID: 34969496 (View on PubMed)

Other Identifiers

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CA001

Identifier Type: -

Identifier Source: org_study_id

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