Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by Ivabradine
Status:
Unknown status
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
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.