Ignite Creation Date:
2024-05-05 @ 10:45 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01186783
Status:
UNKNOWN
Last Update Posted:
2010-09-08
First Post:
2010-08-17
Brief Title:
Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome MODS by Ivabradine
Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Organization:
Martin-Luther-Universität Halle-Wittenberg
Study Overview
Official Title:
Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome MODS by the Funny Channel Current If Inhibitor Ivabradine
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MODIfY
Brief 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None