NCT03266029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

March 5, 2021

Status Verified

February 1, 2021

Enrollment Period

5.2 years

First QC Date

August 19, 2017

Last Update Submit

March 2, 2021

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

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

    Anyalysis of voice recordings; admission vs. discharge

    5 years

Interventions

Cordio AppDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitals/ CHF clinics

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Facility

Haifa, Israel

Location

Related Publications (1)

  • 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.

    PMID: 34969496DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Zaher Azzam, Prof.

    Rambam Health Care Facility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2017

First Posted

August 29, 2017

Study Start

May 24, 2015

Primary Completion

August 1, 2020

Study Completion

December 10, 2020

Last Updated

March 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)