Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology

NCT02068118 | Completed Results DMC

• 1 other identifier: 2012-A01672-41
• Study Type: interventional
• Target: 990
• Locations: 2 countries
• Sites: 38

Brief Summary

Targeted population: Patients with heart failure causing hospitalization during the last twelve months. Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the reference group (standard follow-up care). An 18 months period of observation is required. Main goal: To compare the rate of all cause deaths and hospitalizations of patients with heart failure between the Telecardiology group and the reference group after 18 months of monitoring.

Conditions

Chronic Heart Failure

Keywords

E health; Telemonitoring; Prevention; Heart Failure; Cordiva; Telecardiology Program; Remote Patient Management; Education

Outcome Measures

Primary Outcomes (3)

• Number of All Causes Deaths and (Unplanned) Hospitalizations

  Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)

  18 months

• Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients

  Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)

  18 months

• Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients

  Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)

  18 months

Secondary Outcomes (14)

• Time to First Unplanned Hospital Readmission or Death From Any Cause

  18 months

• All Causes Deaths - Number of Patients Who Died From Any Cause

  18 months

• Time to Death From Any Cause

  18 months

• Number of Unplanned Hospitalizations for Any Cause

  18 months

• Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause

  18 months

Study Arms (2)

Standard care

NO INTERVENTION

Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists

Tele-cardiology group

EXPERIMENTAL

Telecardiology Program

Device: Telecardiology program

Interventions

Telecardiology program DEVICE

The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.

Tele-cardiology group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Men or women patient with heart failure having been hospitalized for cardiac decompensation during the last 12 months.
• Patient with access to a wireline telephone service or GPRS network.
• The patient is willing and able to sign an informed written consent
• Patient is insured under the social security system

You may not qualify if:

• No available echocardiographic evaluation.
• BNP lower than 100pg/ml or NT-proBNP lower than 300pg/ml
• A prognosis of a life span of less than 12 months (apart from heart failure)
• Dialysis patients
• Heart transplant or cardiac assist devices
• Patients involved in inotropic treatment
• Patient doesn't have the necessary autonomy to use the equipment
• Patient enrolled in another clinical trial
• A pregnant or nursing woman, or patient of reproductive age who doesn't use contraceptives
• Patients under tutorship, curatorship or judicial protection
• Participation in the open extension period is only offered to patients who participated in the comparative period of the study, did not withdraw prematurely from the latter and gave their free informed written consent to participate to the extension period.

Sponsors & Collaborators

• CDM e-Health: lead

Study Sites (38)

Cabinet de Cardiologie - Pôle médical spécialisé

Béziers, Languedoc-Rousillon, 34500, France

Location

Centre Hospitalier de Béziers

Béziers, Languedoc-Roussillon, 34500, France

Location

Cabinet libéral

Saint-Yrieix-la-Perche, Limousin, 87500, France

Location

Cabinet libéral de Cardiologie du Muret

Muret, Midi-pyrenées, 31600, France

Location

Centre Hospitalier Général d'Auch

Auch, Midi-Pyrénées, 32008, France

Location

Centre de réadaptation cardiovasculaire Midi-Gascogne

Beaumont-de-Lomagne, Midi-Pyrénées, 82500, France

Location

Centre Hospitalier de Cahors

Cahors, Midi-Pyrénées, 46000, France

Location

Centre Hospitalier Intercommunal Castres-Mazamet

Castres, Midi-Pyrénées, 81108, France

Location

Clinique des Cèdres

Cornebarrieu, Midi-Pyrénées, 31700, France

Location

Clinique de l'Union et du Vaurais

L'Union, Midi-Pyrénées, 31240, France

Location

Clinique du Pont de Chaume

Montauban, Midi-Pyrénées, 82000, France

Location

Centre Hospitalier de Rodez

Rodez, Midi-Pyrénées, 12027, France

Location

Centre Hospitalier Intercommunal du Val d'Ariège

Saint-Jean-de-Verges, Midi-Pyrénées, 09000, France

Location

Polyclinique de l'Ormeau

Tarbes, Midi-Pyrénées, 65000, France

Location

Centre Hospitalier Universitaire de Toulouse - Hôpital de Rangueil

Toulouse, Midi-Pyrénées, 31059, France

Location

Clinique Pasteur

Toulouse, Midi-Pyrénées, 31076, France

Location

Hôpital Joseph Ducuing

Toulouse, Midi-Pyrénées, 31076, France

Location

Centre Hospitalier Universitaire d'Amiens de Picardie

Amiens, 80054, France

Location

Centre Hospitalier Universitaire d'Angers

Angers, 49100, France

Location

Centre Hospitalier d'Avignon - Hospital Henri Duffaut

Avignon, 84090, France

Location

Centre Hospitalier de Bastia

Bastia, 20604, France

Location

Centre Hospitalier Universitaire Bordeaux - Hôpital Saint André

Bordeaux, 33000, France

Location

Centre Hospitalier Universitaire de Brest

Brest, 29200, France

Location

Centre Hospitalier Universitaire de Lyon - Hôpital Louis Pradel

Bron, 69500, France

Location

Centre Hospitalier Universitaire François Mitterrand - Cardiologie 2 : Rythmologie et Insuffisance Cardiaque

Dijon, 21000, France

Location

Centre Hospitalier Universitaire François Mitterrand - Cardiologie Générale

Dijon, 21079, France

Location

Hôpital Léon Bérard

Hyères, 83418, France

Location

Centre Hospitalier Universitaire de Grenoble - Hôpital Antoine Michallon

La Tronche, 38700, France

Location

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, 87042, France

Location

Centre Hospitalier Universitaire de Marseille - Hôpital Nord

Marseille, 13015, France

Location

Centre Hospitalier Régional Universitaire de Montpellier

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire de Nice - Hôpital Pasteur

Nice, 06000, France

Location

Centre Hospitalier Universitaire Caremeau

Nîmes, 30000, France

Location

Centre Hospitalier de Pau

Pau, 64420, France

Location

Centre Hospitalier Universitaire Bordeaux - Hôpital Haut Lévêque

Pessac, 33600, France

Location

Centre Hospitalier de Périgueux

Périgueux, 24000, France

Location

Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer

Toulon, 83056, France

Location

Centre Hospitalier Universitaire de Martinique

Fort-de-France, 97200, Martinique

Location

Related Publications (1)

• Galinier M, Roubille F, Berdague P, Brierre G, Cantie P, Dary P, Ferradou JM, Fondard O, Labarre JP, Mansourati J, Picard F, Ricci JE, Salvat M, Tartiere L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investigators. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020 Jun;22(6):985-994. doi: 10.1002/ejhf.1906. Epub 2020 Jun 15.

  PMID: 32438483 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

There is no significant methodological limitation in this study.

Results Point of Contact

• Title: Clinical Development Physician
• Organization: CDM e-Health

fralsi-ctpublication@airliquide.com

33 (0) 1 39 07 62 86

Study Officials

• Michel GALINIER, MD-PhD

  Rangueil University Hospital - Toulouse

  PRINCIPAL INVESTIGATOR

• Atul PATHAK, MD-PhD

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 21, 2014
• Study Start: May 1, 2013
• Primary Completion: December 20, 2017
• Study Completion: September 28, 2018
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-09

Locations

FR (37); MA (1)