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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00832442
First received: January 28, 2009
Last updated: May 8, 2012
Last verified: January 2009
  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

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • Metoprolol
  • Bucindolol
  • Carvedilol
  • Bisoprolol
  • Nebivolol
Placebo Other: Placebo
in addition to usual care

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832442

Locations
United Kingdom
Clinical Trials & Evaluation Unit, Royal Brompton Hospital
London, United Kingdom
Centre for Statistics in Medicine, University of Oxford
Oxford, United Kingdom
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
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
  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 April 17, 2014