NCT02411279

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 17, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

March 17, 2015

Last Update Submit

May 18, 2017

Conditions

Keywords

Heart failuretelemonitoringintrusive sensorsintrusive devicesHeart failure stage IIHeart failure stage IIIheart disease

Outcome Measures

Primary Outcomes (1)

  • Anticipation and detection of heart failure with automatic treatment of information derived from non intrusive sensors and devices

    patient's medical data will be controlled remotely by health professional for the duration of hospital stay, up to 1 year]

Study Arms (2)

Groupe 1: experimental group

Equiped group with telemedicine systems

Other: Equiped group with telemedicine systems

Groupe 2: control group

Non equiped group with telemedicine systems

Interventions

Groupe 1: experimental group

Eligibility Criteria

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

Population with heart failure stage II and III

You may qualify if:

  • Population with heart failure stage II and III

You may not qualify if:

  • Population whose age is less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine Interne, diabète et maladies métaboliques - Médicale B

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Heart FailureHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • ANDRES Emmanuel, MD, PhD

    Strasbourg University Hospital, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 17, 2015

First Posted

April 8, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 19, 2017

Record last verified: 2017-05

Locations