NCT03714126

Completed

Remote Speech Analysis in HF Patients Undergoing Haemodialys...

Cordio Medical Source

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Other study identifiers

Sponsor study identifier

CLN0014

Study Type

observational

Actual enrollment (reported)

6

Locations

1 country

Sites

1

Timeline

Study Start

March 27, 2019

Actual (reported)

Primary Completion

March 8, 2021

Actual (reported)

Study Completion

March 8, 2021

Actual (reported)

Brief 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. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 6 participants
Study completion date: March 8, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 17, 2018
Actual (reported)
First Posted
October 22, 2018
Actual (reported)
Study Start
March 27, 2019
Actual (reported)
Primary Completion
March 8, 2021
Actual (reported)
Study Completion
March 8, 2021
Actual (reported)

Last Updated: March 9, 2021
Status Verified: April 2020
Last Update Submitted: March 8, 2021

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

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.
throughout study, upto 60 days per patient

Study Arms (1)

HF patients

HF patients will use the Cordio Medical app to record in their hospital visits and at home.

Device: Cordio Medical

Interventions

Cordio MedicalDevice

Recording to an app, no interference to the regular care

HF patients

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Acute and Chronic Congestive Heart Failure patients, undergoing hemodialysis in order to balance their volume overload.

You may qualify if:

Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload.

Sponsors & Collaborators

Cordio Medical
Industrylead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

Ittamar Gork, Dr.
Hadassah Ein Kerem
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: OTHER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 22, 2018

Study Start

March 27, 2019

Actual (reported)

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Unknown

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Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure

Not ApplicableCompleted

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Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency

Phase 4Withdrawn

NCT04870918

Self-care Intervention for Reducing Rehospitalization for Heart Failure: a Randomized Clinical Trial (SIHF)

Not ApplicableCompleted

NCT04203576

First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)

Not ApplicableActive Not Recruiting

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

March 8, 2021

Actual (reported)

Study Completion

March 8, 2021

Actual (reported)

Last Updated

March 9, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03714126
Data provider: ClinicalTrials.gov
Source updated: 2021-03-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:48 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

HF patients

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations