Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing | RxWiki

Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Ventricular Tachycardia
Intervention	Drug: clonidine Drug: metoprolol
Phase	N/A
Sponsor	University of Iowa
Responsible Party	University of Iowa
ClinicalTrials.gov Identifier	NCT00585871
First Received	December 29, 2007
Last Updated	December 9, 2013
Last verified	August 2013

Tracking Information[ + expand ][ + ]

First Received Date	December 29, 2007
Last Updated Date	December 9, 2013
Start Date	May 2006
Estimated Primary Completion Date	January 2012
Current Primary Outcome Measures	episodes of non-sustained ventricular tachycardia [Time Frame: one year] [Designated as safety issue: No]
Current Secondary Outcome Measures	defibrillator shocks [Time Frame: one year] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Official Title	Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Brief Summary	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.
Detailed Description	we had wanted very commonly occurring VT episodes on ICD interrogation: 5 episodes/ 3months. We could not enroll more than 8 patients most of which have interventions to prevent episodes. Thus we could not enroll patients and discontinued the study in the first year.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Condition	Ventricular Tachycardia
Intervention	Drug: clonidine 0.1 mg tid Drug: metoprolol 25 mg tid
Study Arm (s)	Experimental: 1 clonidine 0.1 TID Active Comparator: 2 metoprolol 25 TID

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	8
Estimated Completion Date	January 2012
Estimated Primary Completion Date	January 2012
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00585871
Other Study ID Numbers	200602703
Has Data Monitoring Committee	Yes
Information Provided By	University of Iowa
Study Sponsor	University of Iowa
Collaborators	National Center for Research Resources (NCRR)
Investigators	Principal Investigator: james b martins, md University of Iowa
Verification Date	August 2013

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