Full Text View
Tabular View
No Study Results Posted
Related Studies
Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
This study is currently recruiting participants.
Study NCT00585871   Information provided by University of Iowa
First Received: December 29, 2007   Last Updated: January 2, 2008   History of Changes

December 29, 2007
January 2, 2008
May 2006
May 2008   (final data collection date for primary outcome measure)
episodes of non-sustained ventricular tachycardia [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585871 on ClinicalTrials.gov Archive Site
defibrillator shocks [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
 
Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

Cardiac arrest or sustained VT (ventricular tachycardia) in patients with heart disease is best treated with an ICD (implantable cardioverter defibrillator). However, the ICD alone is not appropriate therapy for patients with frequent VT episodes. In fact frequent shocks for VT may predict a poorer prognosis. Anti-arrhythmic drugs are co-administered with ICDs in up to 50% of patients to prevent VT episodes, but antiarrhythmic drugs may have harmful effects. Thus improved drugs to prevent VT without interfering with ICD function are needed. Recent data including our own suggest that clonidine may be a new therapy to prevent ICD shocks. It may act centrally on sympathetic outflow and peripherally and selectively on cardiac Purkinje, to suppress and control VT occurring in patients. Our purpose is to test the hypothesis that clonidine reduces frequent VT better than beta blocker in patients with ICDs. After informed consent patients will be randomized in a single blind fashion to either clonidine or metoprolol given three times per day. Other prescribed drugs may be adjusted to promote toleration of the study drug. ICD interrogations of episodes of VT will be the primary endpoint. Device based NIPS (non-invasive programmed stimulation) testing in a subset of these patients will allow mechanistic understanding of the clonidine effect. All of the procedural techniques are in place as performed clinically; preliminary data are given showing feasibility of the project.

 
 
Interventional
Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Ventricular Tachycardia
  • Drug: clonidine
  • Drug: metoprolol
  • Experimental: clonidine 0.1 TID
  • Other: metoprolol 25 TID
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
2
 
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Implantable defibrillator treated patients with 5 episodes of ventricular tachycardia per 3 month period

Exclusion Criteria:

  • No more than one shock/3 months
  • No contraindication to clonidine
  • Non-compliance
  • Asthma
Both
18 Years to 85 Years
No
Contact: james b martins, md 319-356-2740 james-martins@uiowa.edu
United States
 
NCT00585871
James Martins, MD, General Clinical Research Center
200602703
University of Iowa
National Center for Research Resources (NCRR)
Principal Investigator: james b martins, md University of Iowa
University of Iowa
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP