Multiple Organ Dysfunction Syndrome Clinical Trial
Official title:
Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by the "Funny Channel" Current (If) Inhibitor Ivabradine
MODIfY is a prospective, single center, open label, randomized, controlled two arms, Phase II-trial to evaluate the ability of ivabradine to reduce an elevated heart rate in Multiple Organ Dysfunction Syndrome (MODS) patients. The primary end point is the proportion of patients with a reduction of heart rate 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 (Acute Physiology and Chronic Health Evaluation (APACHE) II-score ≥ 20, diagnosis within ≤ 24 hours), with an elevated heart rate (sinus rhythm with HR ≥ 90 bpm) and contraindications to beta-blockers (BBs). Treatment period will last 4 days. All patients will be followed for up to six months.
Background: 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). A raised heart rate in MODS patients is
associated with a worse prognosis. Beta-blocker (BB) administration showed to improve
autonomic function and exhibited a significantly reduced mortality in MODS. In most cases
negative inotropic effects prevent administration of BB in MODS patients which often are
treated with catecholamines. In this trial we investigate, whether the "funny current" (If)
inhibitor ivabradine is able to reduce pathologically elevated heart rate in MODS- patients.
The investigators hypothesized that critically ill patients could derive particular benefit
from the specific HR-lowering agent ivabradine.
Methods: MODIfY is a prospective, single center, open label, randomized, controlled two
arms, Phase II-trial to evaluate the ability of ivabradine to reduce an elevated heart rate
in MODS patients. The primary end point is the proportion of patients with a reduction of
heart rate 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 (Acute Physiology and
Chronic Health Evaluation (APACHE) II-score ≥20, diagnosis within ≤24 hours), with an
elevated heart rate (sinus rhythm with HR ≥90 bpm) and contraindications to BBs. Treatment
period will last 4 days. All patients will be followed for up to six months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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