Heart Failure, CongestivePhase 4BConvincedNCT00162565
Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening
A Phase 4 study testing beta-blocker treatment in people with Heart Failure, Congestive, run by Assistance Publique - Hôpitaux de Paris at 32 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- beta-blocker treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 32 sitesFrance
- Study dates
- Nov 2004to Feb 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.
- Left ventricular ejection fraction less than 40%
Who cannot join
- Indication of intravenous positive inotropic treatment
- Indication to withdraw beta-blocker treatment
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
Hôpital Victor Dupuy
Argenteuil, 95107
Les Etablissements Hospitaliers du Bessin
Bayeux, 14401
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Centre Hospitalier Universitaire de Caen
Caen, 14033
Hôpital Fontenoy de Chartres
Chartres, 28018
Centre Hospitalier de Cholet
Cholet, 49325
Hôpital Antoine Béclère
Clamart, 92141
Hôpital Beaujon
Clichy, 92118
Hôpital de Corbeil
Corbeil, 91106
Hôpital Henri Mondor
Créteil, 94000
Hôpital du Bocage
Dijon, 21000
Hôpital A. Michallon
Grenoble, 38009
Centre Hospitalier de Versailles
Le Chesnay, 78157
Hôpital Saint-Philibert
Lomme, 59462
Hôpital Saint-Joseph Saint-Luc
Lyon, 69007
Hôpital de la Timone
Marseille, 13005
Hôpital Arnaud de Villeneuve
Montpellier, 34295
Hôpital René Laënnec
Nantes, 44093
Hôpital Pasteur
Nice, 06002
Hôpital des Armées du Val de Grâce
Paris, 75005
Hôpital Lariboisière
Paris, 75010
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Saint-Michel
Paris, 75015
Centre Hospitalier Universitaire La Milétrie
Poitiers, 86021
Centre Hospitalier Regional Dubos
Pontoise, 95301
Centre Hospitalier Universitaire Potcaillou
Rennes, 35033
Hôpital Charles Nicolle
Rouen, 76031
Centre Hospitalier Universitaire Hautepierre
Strasbourg, 67098
Hôpital de Rangueil
Toulouse, 31403
Hôpital Trousseau
Tours, 37044
Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)
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.
Read the detailed description
Therapeutic strategy of beta-blocker treatment during an episode of heart failure worsening remains unclear. The objective of the B-Convinced study is to demonstrate that continuation of beta-blocker treatment in case of hospitalisation for heart failure worsening is as safe as the interruption of such treatment.
Hypothesis: The proportion of patients clinically improving within 3 days is not inferior when beta-blocker treatment is maintained compared to beta-blocker interruption in case of hospitalisation for heart failure worsening with pulmonary oedema.
Design: Open, randomized non-inferiority trial on two parallel groups of patients. Randomization performed centrally with a vocal server.
Tested Hypothesis: 90% of success in the interruption group, power of 80%, non-inferiority limit of 15% (relative reduction). 162 patients are required with such a hypothesis.
Primary Endpoint: Clinical improvement within 3 days of hospital admission evaluated by the investigator by a standardized questionnaire.
Secondary Endpoints: Clinical improvement at day 8 or at hospital discharge, morbidity-mortality at 4 months.
34 participating centres in France.
- Conditions
- Heart Failure, Congestive
- Being tested
- beta-blocker treatment
- Keywords
- Heart Failure, Congestive, beta-Adrenergic Blockers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-blocker treatmentDrug
beta-blocker treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | bbloquant treatment Receives: Drug: beta-blocker treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion.
Measured: at day 3 of hospital admission
Secondary outcomes (3)
Clinical status (evaluation by investigator and autoevaluation by patient)
Measured: at day 8 after hospital admission
BNP change
Measured: between admission, day 3 and day 8
Mortality, hospital admission, % of patients with beta-blocker treatment
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Philippe P Lechat, MD, PhD, Study director, Hopital Pitie-Salpetriere, Paris, FranceGuillaume Jondeau, MD, PhD, Principal investigator, Hopital Ambroise-Pare, Boulogne, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162565
- Sponsor's protocol ID
- P030414
- Acronym
- BConvinced
- Status last verified
- Aug 2005
- First submitted
- 9 Sep 2005
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)
- ClinicalTrials.gov ID
- NCT00162565
- Acronym / sponsor ID
- BConvinced / P030414
- Conditions
- Heart Failure, Congestive
- Keywords
- Heart Failure, Congestive, beta-Adrenergic Blockers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Therapeutic strategy of beta-blocker treatment during an episode of heart failure worsening remains unclear. The objective of the B-Convinced study is to demonstrate that continuation of beta-blocker treatment in case of hospitalisation for heart failure worsening is as safe as the interruption of such treatment.
Hypothesis: The proportion of patients clinically improving within 3 days is not inferior when beta-blocker treatment is maintained compared to beta-blocker interruption in case of hospitalisation for heart failure worsening with pulmonary oedema.
Design: Open, randomized non-inferiority trial on two parallel groups of patients. Randomization performed centrally with a vocal server.
Tested Hypothesis: 90% of success in the interruption group, power of 80%, non-inferiority limit of 15% (relative reduction). 162 patients are required with such a hypothesis.
Primary Endpoint: Clinical improvement within 3 days of hospital admission evaluated by the investigator by a standardized questionnaire.
Secondary Endpoints: Clinical improvement at day 8 or at hospital discharge, morbidity-mortality at 4 months.
34 participating centres in France.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: beta-blocker treatmentbbloquant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.
- Left ventricular ejection fraction less than 40%
Key exclusion criteria (2 listed)
- Indication of intravenous positive inotropic treatment
- Indication to withdraw beta-blocker treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beta-blocker treatmentbeta-blocker treatment | Drug | 1 |
Primary outcome
Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion.
Time frame: at day 3 of hospital admission
3 secondary outcomes
Clinical status (evaluation by investigator and autoevaluation by patient)
Time frame: at day 8 after hospital admission
BNP change
Time frame: between admission, day 3 and day 8
Mortality, hospital admission, % of patients with beta-blocker treatment
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe P Lechat, MD, PhD study director
Hopital Pitie-Salpetriere, Paris, France
Guillaume Jondeau, MD, PhD principal investigator
Hopital Ambroise-Pare, Boulogne, France
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing beta-blocker treatment in people with Heart Failure, Congestive, run by Assistance Publique - Hôpitaux de Paris at 32 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion. (time frame: at day 3 of hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2009.