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 |
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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
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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 or disease | Intervention/treatment |
|---|---|
| Heart Failure | Drug: Beta blocker Other: Placebo |
| Study Type : | Observational |
| Estimated Enrollment : | 18240 participants |
| Official Title: | Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure |
| Study Start Date : | August 2008 |
| Estimated Primary Completion Date : | December 2012 |
| Estimated Study Completion Date : | December 2012 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Beta blocker |
Drug: Beta blocker
as determined by individual study
Other Names:
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| Placebo |
Other: Placebo
in addition to usual care |
- Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis [ Time Frame: variable (time to event) ]
- 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) ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832442
| 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 |
Additional Information:
Publications:
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 |
| First Posted: | January 30, 2009 Key Record Dates |
| Last Update Posted: | May 9, 2012 |
| Last Verified: | January 2009 |
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Beta blocker Heart Failure Meta analysis Individual patient data |
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Heart Failure Heart Diseases Cardiovascular Diseases Adrenergic beta-Antagonists Physiological Effects of Drugs |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |