NCT02110433

Brief Summary

Heart failure is a serious and common disease. HF is marked by a high rate of preventable hospitalizations through proper care. As such, it is a key target for telemedicine programs. However, currently published data are inconclusive. Investigators propose a multicenter randomized study of innovative telemedicine involving the usual patient monitoring daily weight monitoring, clinical signs and in one of three groups in our study of BNP testing in the patient's home all associated with a regular education reinforcement. The objective is to identify early cardiac decompensation to allow to treat ambulatory and thus prevent the occurrence of more serious events such as death or rehospitalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 2, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

March 7, 2014

Last Update Submit

August 1, 2019

Conditions

Chronic Heart Failure

Keywords

chronic heart failureBNPtelemedicinetelemonitoringweighteducationself managementcost effectiveness

Outcome Measures

Primary Outcomes (1)

  • Primary end point is a composite end point including unplanned hospitalizations for CHF with hospital stay > 1 day / all-cause death / non-programmed emergency department admission related to CHF

    Unplanned hospitalizations for CHF with hospital stay \> 1 day / all-cause death / non-programmed emergency department admission related to CHF

    Follow up 12 months after inclusion

Secondary Outcomes (9)

  • Number of emergency admission.

    12 months

  • Number of all cause death.

    12 months

  • Number of HF hospitalizations

    12 months

  • Adherence to the strategy

    12 months

  • Evaluation of life quality .

    12 months

  • +4 more secondary outcomes

Study Arms (3)

Placebo group

OTHER

Patients will be managed per consensus guidelines Clinicians could see the patients as many times as necessary in order to optimize their therapy and could make BNP measurement (but not using Home BNP monitoring)

Device: Placebo group

Cordiva System (R)

EXPERIMENTAL

Patient will see their cardiologist every three months and benefit from telemonitoring of their weight and general well being through a specific communicant device.

Device: Cordiva System (R)

BNP and Cordiva (R) monitoring system

ACTIVE COMPARATOR

In this group, patients and doctors have access to the platform detailed above (Cordiva (R) monitoring system) and had also access to BNP home monitoring (BNP heartcheck).

Device: Cordiva System (R)Device: BNP heartcheck

Interventions

Placebo groupDEVICE

patient will be managed as recommended by ESC guidelines and follow up will be in accordance to ESC recommendations

Placebo group
Cordiva System (R)DEVICE

Patients have to answer to 8 specific binary questions based on the main precipitating factors for decompensation and measure their body weight every day. If not they will be contact after two missing measures. Patient will be contact by phone call every month in order to reinforce the initial patient therapeutic education and patient-'s compliance. Patient have access to specific printed documents and to a specific web based platform where he can find some PowerPoint presentation on CHF aetiology, signs and therapy and where he can try to answer to monthly quiz in whom questions are based on key messages about CHF according to guidelines and consensus paper on patient therapeutic education.

BNP and Cordiva (R) monitoring systemCordiva System (R)
BNP heartcheckDEVICE

Patients had to measure the BNP plasma level using Alere home based BNP device heartcheck in a weekly basis in order to follow this parameter up. In case of clinical signs of CHF or a significant weight increase identified by the tele monitoring or the patient, the nurse will ask to the patient to do an extra measurement of home BNP testing in order to exclude a CHF decompensation (BNP \< 100 pg/ml or remaining stable (\< 30% increase).

BNP and Cordiva (R) monitoring system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure diagnosed on a first hospitalization for acute exacerbation during the last twelve months, without high age limit
  • Men or women
  • More than 18 years old
  • Minimal knowledge of the French language (patient or his relatives)
  • The patient need to fill an informed written consent
  • Patient resides or is treated in Ile de France
  • Patient is insured under the social security system

You may not qualify if:

  • Myocardial infarction or revascularization or Heart Valve Surgery \< 3 months
  • Inability to execute the feasibility test
  • Major cognitive disorders do not allow access to the platform
  • Patient does not have the necessary autonomy to use the equipment
  • Sensitive subject, under Article L32 of the Code of Public Health
  • Patient enrolled in another clinical trial
  • Renal failure with creatininemia clearance (cockcroft) \<15 ml/min
  • h/day oxygen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Victor Dupouy Hospital

Argenteuil, 95, France

Location

Sud francilien Hospital

Corbeil-Essonnes, 91106, France

Location

Henri-Mondor Hospital

Créteil, 94, France

Location

Simone Veil Hospital

Eaubonne, 95, France

Location

Bernard Clinic

Ermont, 95, France

Location

Gonesse Hospital

Gonesse, France

Location

Versailles Hospital

Le Chesnay, 78157, France

Location

Orsay Hospital

Longjumeau, 91160, France

Location

Meaux Hospital

Meaux, 77104, France

Location

Sainte Marie Clinic

Osny, 95, France

Location

Georges Pompidou University Hospital

Paris, 75015, France

Location

Mutualiste Montsouris Institute

Paris, 75, France

Location

Turin Clinic

Paris, 75, France

Location

Poissy-Saint-Germain-en-Laye Hospital

Saint-Germain-en-Laye, 78100, France

Location

Centre Hospitalier René DUBOS

Pontoise, Île-de-France Region, 95303, France

Location

Related Publications (1)

  • Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

    PMID: 26857558DERIVED

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick JOURDAIN

    René Dubos Hospital (Pontoise-France)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

April 10, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2017

Study Completion

October 1, 2017

Last Updated

August 2, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(15)