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Heart Failure Educational and Follow up Platform

NCT02110433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-08-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Placebo group

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

DEVICE

Cordiva System (R)

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.

DEVICE

BNP heartcheck

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).

Sponsors & Collaborators

  • Hôpital NOVO

    lead OTHER

Principal Investigators

  • Patrick JOURDAIN · René Dubos Hospital (Pontoise-France)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-03-31
Completion
2017-10-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02110433 on ClinicalTrials.gov