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Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

This study has been terminated.
(could not recruit)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
James Martins, University of Iowa Identifier:
First received: December 29, 2007
Last updated: December 9, 2013
Last verified: August 2013
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
Ventricular Tachycardia Drug: clonidine Drug: metoprolol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

Resource links provided by NLM:

Further study details as provided by James Martins, University of Iowa:

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

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

Enrollment: 8
Study Start Date: May 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
clonidine 0.1 TID
Drug: clonidine
0.1 mg tid
Active Comparator: 2
metoprolol 25 TID
Drug: metoprolol
25 mg tid

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00585871

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

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
Study First Received: December 29, 2007
Last Updated: December 9, 2013

Keywords provided by James Martins, University of Iowa:
ICD patients with 5 VTs per 3 month period

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
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 processed this record on September 21, 2017