Congestive Heart FailureNCT03266029
Clinical Evaluation of Cordio App in Adult ADHF Patients
An observational study of Congestive Heart Failure, run by Cordio Medical at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Cordio App
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 1 siteIsrael
- Study dates
- 24 May 2015to 10 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Hospitals/ CHF clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Cordio App
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordio AppDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start24 May 2015
- Primary completionAug 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zaher Azzam, Prof., Principal investigator, Rambam Health Care Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266029
- Sponsor's protocol ID
- CA001
- Status last verified
- Feb 2021
- First submitted
- 19 Aug 2017
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34969496
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF
- ClinicalTrials.gov ID
- NCT03266029
- Acronym / sponsor ID
- CA001
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Cordio MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 May 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitals/ CHF clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cordio App | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Derived from this study: PubMed 34969496Amir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaher Azzam, Prof. principal investigator
Rambam Health Care Facility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Cordio Medical at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.