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Sponsors and Collaborators: |
University of Iowa National Center for Research Resources (NCRR) |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00585871 |
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 | Intervention |
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Ventricular Tachycardia |
Drug: clonidine Drug: metoprolol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
Official Title: | Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing |
Estimated Enrollment: | 2 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
clonidine 0.1 TID
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Drug: clonidine
0.1 mg tid
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2
metoprolol 25 TID
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Drug: metoprolol
25 mg tid
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: james b martins, md | 319-356-2740 | james-martins@uiowa.edu |
United States, Iowa | |
UIHC | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: james b martins, md 319-356-2740 james-martins@uiowa.edu |
Principal Investigator: | james b martins, md | University of Iowa |
Responsible Party: | General Clinical Research Center ( James Martins, MD ) |
Study ID Numbers: | 200602703 |
Study First Received: | December 29, 2007 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00585871 |
Health Authority: | United States: Institutional Review Board |
implantable defibrillator treated patients with 5 episodes of ventricular tachycardia per 3 month period |
Heart Diseases Metoprolol succinate Tachycardia Clonidine |
Metoprolol Tachycardia, Ventricular Arrhythmias, Cardiac |
Sympatholytics Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions Pathologic Processes |
Sensory System Agents Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents |