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

Royal Brompton & Harefield NHS Foundation Trust

Status

Unknown

Conditions

Heart Failure

Treatments

Other: Placebo

Drug: Beta blocker

Study type

Observational

Funder types

Other

Identifiers

NCT00832442

CTEU08/d5/BBHF

Details and patient eligibility

About

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.

Enrollment

18,240 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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