What question did this study set out to answer?

To establish the study rationale and protocol comparing the effects of initial bisoprolol versus initial enalapril monotherapy on combined mortality and hospitalization in chronic heart failure.

May 1, 2004European Journal of Heart FailureOpen Access

Comparison of Treatment Initiation with Bisoprolol Vs. Enalapril in Chronic Heart Failure Patients: Rationale and Design of CIBIS-III

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Why the study?

Does initial monotherapy with bisoprolol compared to enalapril reduce combined death or hospitalisation in chronic heart failure patients?

Population

1,000 chronic heart failure patients without ACE-inhibitor, beta-blocker or angiotensin-receptor-blocker…

Comparison

Initial monotherapy with bisoprolol for 6… vs Initial monotherapy with enalapril for 6 months…

Design

Other, 1:1

Follow-up

12 to 24 months

Authors

RWRonnie WillenheimerHeart Failure & Transplant EEErland ErdmannHeart Failure & Transplant FFFerenc FolláthUniversity of Modena and Reggio Emilia

Discussion

Member takes

Implication

The CIBIS-III trial is designed to determine if initiating heart failure treatment with bisoprolol is non-inferior or superior to initiating with enalapril.

Key Points

To establish the study rationale and protocol comparing the effects of initial bisoprolol versus initial enalapril monotherapy on combined mortality and hospitalization in chronic heart failure.
Randomized trial planning 1:1 allocation of 1,000 patients with chronic heart failure who are naive to ACE inhibitors, beta-blockers, and ARBs.
Participants receive 6 months of initial monotherapy with either bisoprolol or enalapril, followed by combined therapy for 6 to 18 months.
Primary endpoint assesses noninferiority of bisoprolol-first versus enalapril-first on combined all-cause mortality or hospitalization, followed by superiority testing if noninferiority is confirmed.
Protocol paper detailing trial rationale; primary event rates and hazard ratios are pending trial completion.
Demonstrating noninferiority supports clinical discretion in initial drug selection, whereas demonstrating superiority would shift guidelines to recommend initiating beta-blockers before ACE inhibitors.

Structured PICO

Does initial monotherapy with bisoprolol compared to enalapril reduce combined death or hospitalisation in chronic heart failure patients?

Population

1,000 chronic heart failure (CHF) patients without ACE-inhibitor, beta-blocker or angiotensin-receptor-blocker therapy

Intervention

Initial monotherapy with bisoprolol for 6 months, followed by combined therapy (with enalapril) for 6-18 months

Comparator

Initial monotherapy with enalapril for 6 months, followed by combined therapy (with bisoprolol) for 6-18 months

Outcome

Combined death or hospitalisationcomposite

The CIBIS-III trial is designed to determine if initiating heart failure treatment with bisoprolol is non-inferior or superior to initiating with enalapril.

Cite This Study

Willenheimer et al. (2004) studied this question.

synapsesocial.com/papers/6a7223596c240de38cdc50a7 https://doi.org/10.1016/j.ejheart.2003.12.016

Topics

HFrEF treatment Heart failure

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Implication

The CIBIS-III trial is designed to determine if initiating heart failure treatment with bisoprolol is non-inferior or superior to initiating with enalapril.

Comparison of Treatment Initiation with Bisoprolol Vs. Enalapril in Chronic Heart Failure Patients: Rationale and Design of CIBIS-III

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

Comparison of Treatment Initiation with Bisoprolol Vs. Enalapril in Chronic Heart Failure Patients: Rationale and Design of CIBIS-III

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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Topics

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