Reducing elevated heart rate in patients with multiple organ dysfunction syndrome by the I f (funny channel current) inhibitor ivabradine
- 543 Downloads
Heart rate (HR) is of relevant prognostic value not only in the general population and patients with cardiovascular disease, but also in critically ill patients with multiple organ dysfunction syndrome (MODS). An elevated HR in MODS patients is associated with a worse prognosis. Beta-blocker (BB) administration has been shown to reduce mortality in MODS. In most cases, negative inotropic effects prevent administration of BBs in MODS patients. In this trial we investigate, whether the “funny current” (I f) channel inhibitor ivabradine is able and apt to reduce pathologically elevated HR in MODS patients. We hypothesize that critically ill patients could derive particular benefit from the specific HR-lowering agent ivabradine.
MODI fY is a prospective, single centre, open label, randomized, controlled two arms, phase II-trial to evaluate the potential of ivabradine to reduce an elevated HR in MODS patients. The primary end point is the proportion of patients with a reduction of HR by at least 10 beats per minute (bpm) within 4 days. This trial will randomize 70 patients (men and women, aged ≥18 years) with newly diagnosed MODS, with an elevated HR (sinus rhythm with HR ≥90 bpm) and contraindications to BB therapy. Treatment period will last for 4 days. All patients will be followed for 6 months.
The first patient was randomized on May 21, 2010.
The MODI fY trial is the first application of ivabradine as a pure heart rate reducing agent in MODS patients.
KeywordsHeart rate Ivabradine Critically ill patient Multiple organ dysfunction syndrome
Conflict of interest
The MODI fY study is an investigator-driven study which has been supported in part by Servier Company, the company producing ivabradine (Procoralan®). K.W. has received honoraria from Servier Company for lectures, national advisory board activities and participation in clinical trials (BEAUTIFUL, SHIFT, SIGNIFY); K.W. got also financial support from Servier Company for experimental research projects. The other authors declare that they have no conflict of interest.
- 1.Levy R, White P, Stroud W, Hillman C (1945) Studies of blood pressure in Army officers: 4. Transient tachycardia-prognostic significance alone and in association with transient hypertension. JAMA 129:585–588Google Scholar
- 5.Bohm M, Swedberg K, Komajda M et al (2010) Heart rate as a risk factor in chronic heart failure (SHIFT): the association between heart rate and outcomes in a randomised placebo-controlled trial. Lancet Google Scholar
- 8.Conference ACoCPoCCMC (1992) Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med 20:864–74Google Scholar
- 39.Vincent JL, de Mendonca A, Cantraine F et al (1998) Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on “sepsis-related problems” of the European Society of Intensive Care Medicine. Crit Care Med 26:1793–1800PubMedCrossRefGoogle Scholar