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Objectives and design of the BEAUTIFUL Study


Objectives of the BEAUTIFUL study


BEAUTIFUL has 2 main objectives: a clinical one and a pathophysiological one

The first objective was designed1 to evaluate the benefits of ivabradine, on top of optimal guideline-based treatment, on cardiovascular events such as :
  • cardiovascular death,
  • hospitalization for acute myocardial infarction,
  • new-onset or worsening heart failure in stable coronary patients with left ventricular dysfunction.
The second objective was designed to evaluate the effects of elevated heart rate (heart rate >70 bpm) on cardiovascular events in these patients.


Design of the BEAUTIFUL study1

  • BEAUTIFUL was an international, multicenter, randomized, double-blind, placebo-controlled 2-arm trial in 781 centers worldwide.
  • The study was designed to demonstrate the superiority of Ivabradine over placebo in the reduction of cardiovascular mortality, hospital admission for acute myocardial infarction, and hospital admission for new-onset or worsening heart failure (primary composite end point).
  • The study population includes patients who are likely to benefit from the heart rate–lowering effect of Ivabradine (stable coronary artery disease patients with sinus rhythm and left ventricular systolic dysfunction) and who are at high risk of experiencing a cardiovascular event.
  • The background cardiovascular treatment should be considered as an optimal standard of care, and may include a beta-blocker, statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and antiplatelet drugs.
  • During the inclusion visit, patients had a baseline evaluation. Eligible patients were randomized to 1 of the 2 treatment arms, namely, double-blind Ivabradine, or placebo:



    • Design of the BEAUTIFUL study
    • The starting dose of Ivabradine was 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 2 weeks after the inclusion visit with resting heart rate of ≥60 bpm will receive the target dose of 7.5 mg twice daily (or matching placebo).


    B*, signs or symptoms considered as related to bradycardia; 5 mg bid, 5 mg tablet twice daily (or matching placebo);
    7.5 mg bid, 1 7.5 mg tablet twice daily (or matching placebo)

    Doses scheme of the study treatment



    References
    1. Fox K, Ferrari R, Tendera M, Steg PG, Ford I; on behalf of the BEAUTIFUL Steering Committee. Rationale and design of a randomised, double-blind, placebo-controlled trial of ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction: the morBidity-mortality EvAlUaTion of the If inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction (BEAUTIFUL) study. Am Heart J 2006;152:860-866.

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