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Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by Ivabradine

NCT01186783 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2010-09-08

No results posted yet for this study

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.

Conditions

  • Multiple Organ Dysfunction Syndrome

Interventions

DRUG

ivabradine

Patients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or percutaneous endoscopic gastrostomy-probe) of ivabradine for 4 days. Day 1 and 2: 5,0 mg ivabradine b.i.d. if heart rate ≥60bpm (acute renal failure: ≥70bpm) Day 3 and 4: 5,0 mg ivabradine b.i.d. if 60bpm≥heart rate\<90bpm (acute renal failure: 70bpm≥heart rate \<90bpm 7,5 mg ivabradine b.i.d. if heart rate ≥90bpm

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • KKS Netzwerk

    collaborator NETWORK

  • Martin-Luther-Universität Halle-Wittenberg

    lead OTHER

Principal Investigators

  • Karl Werdan, MD, Professor · Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany

  • Henning Ebelt, MD · Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany

  • Sebastian Nuding, MD · Medical Faculty of the Martin-Luther-University Halle-Wittenberg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-11-30
Completion
2012-05-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01186783 on ClinicalTrials.gov