Heart Failuree-INCANCT02411279
Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations
An observational study of Heart Failure, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. 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?
- Equiped group with telemedicine systems
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Sep 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Population with heart failure stage II and III
Who may be able to join
- Population with heart failure stage II and III
Who cannot join
- Population whose age is less than 18 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Interne, diabète et maladies métaboliques - Médicale B
Strasbourg, 67091
Emmanuel ANDRES, MD, PhD, 33 3 88 11 50 66, emmanuel.andres@chru-strasbourg.fr
Emmanuel ANDRES, MD, PhD
About this study
Official title: Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations Derived From Non Intrusive Sensors and Devices
Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries.
The objective of the project is to test an intelligent platform for monitoring at home, using non-intrusive sensors, patients with heart failure, particularly those with stage II and III NYHA. It will assist the medical automating the processing of information from these sensors to detect and report an early stage risk situations.
Patient monitoring, by a system of telemedicine tools associated with motivation and education helps significantly reduce the number of days of hospitalization becomes important when the patient is hospitalized for acute HF.
- Conditions
- Heart Failure
- Being tested
- Equiped group with telemedicine systems
- Keywords
- Heart failure, telemonitoring, intrusive sensors, intrusive devices, Heart failure stage II, Heart failure stage III, heart disease
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equiped group with telemedicine systemsOther
| Study group | Role | What they receive |
|---|---|---|
| Groupe 1: experimental group | Equiped group with telemedicine systems Receives: Other: Equiped group with telemedicine systems | |
| Groupe 2: control group | Non equiped group with telemedicine systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticipation and detection of heart failure with automatic treatment of information derived from non intrusive sensors and devices
Measured: patient's medical data will be controlled remotely by health professional for the duration of hospital stay, up to 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
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.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANDRES Emmanuel, MD, PhD, Principal investigator, Strasbourg University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411279
- Sponsor's protocol ID
- 6155
- Acronym
- e-INCA
- Status last verified
- May 2017
- First submitted
- 17 Mar 2015
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations Derived From Non Intrusive Sensors and Devices
- ClinicalTrials.gov ID
- NCT02411279
- Acronym / sponsor ID
- e-INCA / 6155
- Conditions
- Heart Failure
- Keywords
- Heart failure, telemonitoring, intrusive sensors, intrusive devices, Heart failure stage II, Heart failure stage III, heart disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- 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.
Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries.
The objective of the project is to test an intelligent platform for monitoring at home, using non-intrusive sensors, patients with heart failure, particularly those with stage II and III NYHA. It will assist the medical automating the processing of information from these sensors to detect and report an early stage risk situations.
Patient monitoring, by a system of telemedicine tools associated with motivation and education helps significantly reduce the number of days of hospitalization becomes important when the patient is hospitalized for acute HF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Groupe 1: experimental group | – | Other: Equiped group with telemedicine systemsEquiped group with telemedicine systems |
| Groupe 2: control group | – | –Non equiped group with telemedicine systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with heart failure stage II and III
Key inclusion criteria (1 listed)
- Population with heart failure stage II and III
Key exclusion criteria (1 listed)
- Population whose age is less than 18 years
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 |
|---|---|---|
| Equiped group with telemedicine systems | Other | Groupe 1: experimental group |
Primary outcome
Anticipation and detection of heart failure with automatic treatment of information derived from non intrusive sensors and devices
Time frame: patient's medical data will be controlled remotely by health professional for the duration of hospital stay, up to 1 year]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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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.
ANDRES Emmanuel, MD, PhD principal investigator
Strasbourg University Hospital, France
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 University Hospital, Strasbourg, France at 1 site in France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 May 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANDRES Emmanuel, MD, PhD (333 8811 5066, Emmanuel.ANDRES@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticipation and detection of heart failure with automatic treatment of information derived from non intrusive sensors and devices (time frame: patient's medical data will be controlled remotely by health professional for the duration of hospital stay, up to 1 year]). 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 19 May 2017.