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Trial record 77 of 326 for:    clonidine

Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585871
Recruitment Status : Withdrawn (could not recruit)
First Posted : January 3, 2008
Last Update Posted : July 24, 2018
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
James Martins, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Drug: clonidine Drug: metoprolol Not Applicable

Detailed Description:
we had wanted very commonly occurring VT episodes on ICD interrogation: 5 episodes/ 3 months. We could not enroll more than 2 patients most of which have interventions to prevent episodes. Thus we could not enroll patients and discontinued the study in the first year.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Actual Study Start Date : May 2006
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Clonidine therapy group
clonidine 0.1 TID
Drug: clonidine
0.1 mg tid

Active Comparator: Metoprolol control group
metoprolol 25 TID
Drug: metoprolol
25 mg tid

Primary Outcome Measures :
  1. episodes of non-sustained ventricular tachycardia [ Time Frame: one year ]

Secondary Outcome Measures :
  1. defibrillator shocks [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585871

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United States, Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
James Martins
National Center for Research Resources (NCRR)
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Principal Investigator: james b martins, md University of Iowa

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Responsible Party: James Martins, Professor, University of Iowa Identifier: NCT00585871     History of Changes
Other Study ID Numbers: 200602703
study is over no ID is needed
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by James Martins, University of Iowa:
ICD patients with 5 VTs per 3 month period
Additional relevant MeSH terms:
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Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists