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Clinical Trials/NCT03266029
NCT03266029CompletedNot Applicable

Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF

Cordio Medical1 site in 1 country89 target enrollmentStarted: May 24, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
89
Locations
1
Primary Endpoint
voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)

Time Frame: 5 years

Anyalysis of voice recordings; admission vs. discharge

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Cordio Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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