Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure (BB-META-HF)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Drug: Beta blocker Other: Placebo |
| Study Type: | Observational |
| Official Title: | Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure |
- Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis [ Time Frame: variable (time to event) ] [ Designated as safety issue: No ]
- Beta-blocker therapy improves mortality and morbidity in both elderly patients and women [ Time Frame: variable (time to event) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- The benefit of beta-blockers is not modified by concomitant cardiovascular therapy [ Time Frame: variable (time to event) ] [ Designated as safety issue: No ]
- The benefit of beta-blockers is independent of left ventricular ejection fraction at baseline [ Time Frame: variable (time to event) ] [ Designated as safety issue: No ]
- The clinical benefit is dependent on the resting heart rate achieved whatever the dose achieved or agent used [ Time Frame: variable (time to event) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18240 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Beta blocker |
Drug: Beta blocker
as determined by individual study
Other Names:
|
| Placebo |
Other: Placebo
in addition to usual care
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Meta-Analysis of randomised controlled trials investigating mortality & morbidity of placebo versus beta-blockers in heart failure
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
Contacts and Locations| United Kingdom | |
| Clinical Trials & Evaluation Unit, Royal Brompton Hospital | |
| London, United Kingdom | |
| Centre for Statistics in Medicine, University of Oxford | |
| Oxford, United Kingdom | |
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Royal Brompton & Harefield NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00832442 History of Changes |
| Other Study ID Numbers: | CTEU08/d5/BBHF |
| Study First Received: | January 28, 2009 |
| Last Updated: | May 8, 2012 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
|
Beta blocker Heart Failure Meta analysis Individual patient data |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013