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Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure (BB-META-HF)

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ClinicalTrials.gov Identifier: NCT00832442
Recruitment Status : Unknown
Verified January 2009 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Enrolling by invitation
First Posted : January 30, 2009
Last Update Posted : May 9, 2012
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Tracking Information
First Submitted Date January 28, 2009
First Posted Date January 30, 2009
Last Update Posted Date May 9, 2012
Study Start Date August 2008
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2009)
Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis [ Time Frame: variable (time to event) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00832442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 29, 2009)
  • Beta-blocker therapy improves mortality and morbidity in both elderly patients and women [ Time Frame: variable (time to event) ]
  • Beta-blocker therapy improves mortality and morbidity in patients with co-morbidities (diabetes, renal dysfunction, COPD, peripheral arterial disease or atrial fibrillation) [ Time Frame: variable (time to event) ]
  • The benefit of beta-blockers is not modified by concomitant cardiovascular therapy [ Time Frame: variable (time to event) ]
  • The benefit of beta-blockers is independent of left ventricular ejection fraction at baseline [ Time Frame: variable (time to event) ]
  • The clinical benefit is dependent on the resting heart rate achieved whatever the dose achieved or agent used [ Time Frame: variable (time to event) ]
  • Adverse side effects of beta blocker therapy do not significantly impact on clinical benefit (as a whole and in relevant sub-groups) [ Time Frame: variable (time to event) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure
Official Title Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure
Brief Summary

Several large trials have shown that beta-blocker treatment reduces the risk of death and hospital admission in patients with symptomatic heart failure. Unfortunately, survey data suggests relatively poor utilisation of beta-blockers, despite ample evidence for good tolerability. Additionally there are several important unanswered questions, such as clinical efficacy for specific sub-populations (women, the elderly and patients with diabetes or other co-morbidities) and the effect of beta-blockers in combination with other medications. Previous meta-analyses, based on published tabular data, have been conducted although this approach has important biases and limitations.

We plan to perform a carefully conducted systematic review of individual patient data from the major randomised trials of beta-blockers in heart failure. The goals of this collaborative project are to clarify the overall efficacy of beta-blockers and identify sub-groups that show particular benefit, thereby increasing the use of beta-blockers, reducing adverse clinical outcomes and the high costs associated with this condition.

Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Meta-Analysis of randomised controlled trials investigating mortality & morbidity of placebo versus beta-blockers in heart failure
Condition Heart Failure
Intervention
  • Drug: Beta blocker
    as determined by individual study
    Other Names:
    • Metoprolol
    • Bucindolol
    • Carvedilol
    • Bisoprolol
    • Nebivolol
  • Other: Placebo
    in addition to usual care
Study Groups/Cohorts
  • Beta blocker
    Intervention: Drug: Beta blocker
  • Placebo
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 29, 2009)
18240
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Randomised control trials of beta-blocker versus control in patients with documented heart failure
  • Unconfounded trials only (in which one treatment group differed from another only by the beta-blocker therapy of interest)
  • Randomization process precluded prior knowledge of the next treatment (for example trials in which treatment allocation was alternate or based on odd or even dates would not be included)

Exclusion Criteria:

  • Trial sample size of less than 300 patients
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00832442
Other Study ID Numbers CTEU08/d5/BBHF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor Royal Brompton & Harefield NHS Foundation Trust
Collaborators University of Oxford
Investigators
Study Chair: Marcus Flather Royal Brompton Hospital, London
Study Chair: Luis Manzano Universidad de Alcala, Madrid
Study Chair: Dipak Kotecha Royal Brompton Hospital, London
Study Chair: Henry Krum Monash University, Melbourne
PRS Account Royal Brompton & Harefield NHS Foundation Trust
Verification Date January 2009