NCT00162565

Brief Summary

The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission. 162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_4

Geographic Reach
1 country

32 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

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

May 25, 2009

Status Verified

August 1, 2005

Enrollment Period

4.3 years

First QC Date

September 9, 2005

Last Update Submit

May 22, 2009

Conditions

Heart Failure, Congestive

Keywords

Heart Failure, Congestivebeta-Adrenergic Blockers

Outcome Measures

Primary Outcomes (1)

  • Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion.

    at day 3 of hospital admission

Secondary Outcomes (3)

  • Clinical status (evaluation by investigator and autoevaluation by patient)

    at day 8 after hospital admission

  • BNP change

    between admission, day 3 and day 8

  • Mortality, hospital admission, % of patients with beta-blocker treatment

    at 3 months

Study Arms (1)

1

EXPERIMENTAL

bbloquant treatment

Drug: beta-blocker treatment

Interventions

beta-blocker treatmentDRUG

beta-blocker treatment

1

Eligibility Criteria

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

You may qualify if:

  • Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.
  • Left ventricular ejection fraction less than 40%

You may not qualify if:

  • Indication of intravenous positive inotropic treatment
  • Indication to withdraw beta-blocker treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Hôpital Victor Dupuy

Argenteuil, 95107, France

Location

Les Etablissements Hospitaliers du Bessin

Bayeux, 14401, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Centre Hospitalier Universitaire de Caen

Caen, 14033, France

Location

Hôpital Fontenoy de Chartres

Chartres, 28018, France

Location

Centre Hospitalier de Cholet

Cholet, 49325, France

Location

Hôpital Antoine Béclère

Clamart, 92141, France

Location

Hôpital Beaujon

Clichy, 92118, France

Location

Hôpital de Corbeil

Corbeil, 91106, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Hôpital du Bocage

Dijon, 21000, France

Location

Hôpital A. Michallon

Grenoble, 38009, France

Location

Centre Hospitalier de Versailles

Le Chesnay, 78157, France

Location

Hôpital Saint-Philibert

Lomme, 59462, France

Location

Hôpital Saint-Joseph Saint-Luc

Lyon, 69007, France

Location

Hôpital de la Timone

Marseille, 13005, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hôpital René Laënnec

Nantes, 44093, France

Location

Hôpital Pasteur

Nice, 06002, France

Location

Hôpital des Armées du Val de Grâce

Paris, 75005, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Saint-Michel

Paris, 75015, France

Location

Centre Hospitalier Universitaire La Milétrie

Poitiers, 86021, France

Location

Centre Hospitalier Regional Dubos

Pontoise, 95301, France

Location

Centre Hospitalier Universitaire Potcaillou

Rennes, 35033, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

Centre Hospitalier Universitaire Hautepierre

Strasbourg, 67098, France

Location

Hôpital de Rangueil

Toulouse, 31403, France

Location

Hôpital Trousseau

Tours, 37044, France

Location

Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Philippe P Lechat, MD, PhD

    Hopital Pitie-Salpetriere, Paris, France

    STUDY DIRECTOR

  • Guillaume Jondeau, MD, PhD

    Hopital Ambroise-Pare, Boulogne, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

November 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

May 25, 2009

Record last verified: 2005-08

Locations

FR(32)