Heart FailureNCT03714126
Remote Speech Analysis in HF Patients Undergoing Haemodialysis
An observational study of Heart Failure, run by Cordio Medical at 1 site in Israel.
Trial summary
This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R\&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cordio Medical
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Mar 2019to 8 Mar 2021
- 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: Acute and Chronic Congestive Heart Failure patients, undergoing hemodialysis in order to balance their volume overload.
Who may be able to join
- Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload.
- Class C Heart Failure patient with reduced EF CHF (EF<40%) and NYHA 2-3.
- Patients with dyspnea clinically related to pulmonary congestion
- Patient with more than 3 months HF disease duration.
- The patient is willing to participate as evidenced by signing the written informed consent.
- Male or non-pregnant female patient
Who cannot join
- Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
- Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
- Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA 4.
- Patients with evidence of active Infection.
- Patient with severe alcohol or drug use.
- Psychological instability, inappropriate attitude or motivation.
- Patient with life threatening debilitating disease other than cardiac.
- Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Intervantional Study to Create a Patient Recordings and Clinical Database Using the Cordio System
This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R\&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.
- Conditions
- Heart Failure
- Being tested
- Cordio Medical
- 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 MedicalDevice
Recording to an app, no interference to the regular care
| Study group | Role | What they receive |
|---|---|---|
| HF patients | HF patients will use the Cordio Medical app to record in their hospital visits and at home. Receives: Device: Cordio Medical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CHF patients with and without acute lung accumulation. in R&D Database
The objective of the study is to create a recordings database of CHF patients with and without acute lung accumulation.
Measured: throughout study, upto 60 days per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start27 Mar 2019
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ittamar Gork, Dr., Principal investigator, Hadassah Ein Kerem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714126
- Sponsor's protocol ID
- CLN0014
- Status last verified
- Apr 2020
- First submitted
- 17 Oct 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Intervantional Study to Create a Patient Recordings and Clinical Database Using the Cordio System
- ClinicalTrials.gov ID
- NCT03714126
- Acronym / sponsor ID
- CLN0014
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cordio MedicalIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 22 Oct 2018 (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.
This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R\&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF patients | – | Device: Cordio MedicalHF patients will use the Cordio Medical app to record in their hospital visits and at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute and Chronic Congestive Heart Failure patients, undergoing hemodialysis in order to balance their volume overload.
Key inclusion criteria (6 listed)
- Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload.
- Class C Heart Failure patient with reduced EF CHF (EF<40%) and NYHA 2-3.
- Patients with dyspnea clinically related to pulmonary congestion
- Patient with more than 3 months HF disease duration.
- The patient is willing to participate as evidenced by signing the written informed consent.
Key exclusion criteria (8 listed)
- Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
- Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
- Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA 4.
- Patients with evidence of active Infection.
- Patient 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 MedicalRecording to an app, no interference to the regular care | Device | HF patients |
Primary outcome
Number of CHF patients with and without acute lung accumulation. in R&D Database
Time frame: throughout study, upto 60 days per patient
The objective of the study is to create a recordings database of CHF patients with and without acute lung accumulation.
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 9 Mar 2021.
- 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.
Ittamar Gork, Dr. principal investigator
Hadassah Ein Kerem
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 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 6 inclusion and 8 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 9 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?
Number of CHF patients with and without acute lung accumulation. in R&D Database (time frame: throughout study, upto 60 days per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2021.