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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Collaborators: KKS Netzwerk; Servier

Criteria

Inclusion Criteria:

• Multiple organ dysfunction syndrome (APACHE II score ≥ 20) due to coronary and non-coronary etiology

• Multiple organ dysfunction syndrome diagnosed ≤ 24 h

• Sinus rhythm with heart rate ≥ 90bpm

• Existing contraindications to beta-receptor blockade

• Written informed consent or identified or suspected positive will with respect to the trial treatment

Exclusion Criteria:

• Patients who have not yet completed the 18th year of age

• Pregnancy, lactation

• Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate <30ml/min

• Patients with malignant hyperthermia

• Burn patients

• Patients with acute rejection after organ transplantation

• Patients with bleedings and need for transfusion

• Resuscitated patients with suspected hypoxic brain injury

• Patients who have participated or participate in other studies within the last 3 months

• Other types of shock than septic or cardiogenic shock

• Patients with severe valvular heart disease

• Hypersensitivity to the active substance or any of the excipients

• Severe hepatic insufficiency

• Sick sinus syndrome

• Sinu-atrial block

• pacemaker-dependency

• 3rd degree AV block

• Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Summary of Product Characteristics (SPC))