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

May 8, 2012 updated by: Royal Brompton & Harefield NHS Foundation Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

18240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Clinical Trials & Evaluation Unit, Royal Brompton Hospital
      • Oxford, United Kingdom
        • Centre for Statistics in Medicine, University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Meta-Analysis of randomised controlled trials investigating mortality & morbidity of placebo versus beta-blockers in heart failure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Placebo
Other: Placebo
in addition to usual care
Beta blocker
Drug: Beta blocker
as determined by individual study
Other Names:
  • Nebivolol
  • Metoprolol
  • Carvedilol
  • Bucindolol
  • Bisoprolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis
Time Frame: variable (time to event)
variable (time to event)

Secondary Outcome Measures

Outcome Measure
Time Frame
Beta-blocker therapy improves mortality and morbidity in both elderly patients and women
Time Frame: variable (time to event)
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)
variable (time to event)
The benefit of beta-blockers is not modified by concomitant cardiovascular therapy
Time Frame: variable (time to event)
variable (time to event)
The benefit of beta-blockers is independent of left ventricular ejection fraction at baseline
Time Frame: variable (time to event)
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)
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)
variable (time to event)

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (ESTIMATE)

January 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTEU08/d5/BBHF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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