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Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
This study is currently recruiting participants.
Verified by University of Iowa, December 2007
First Received: December 29, 2007   Last Updated: January 2, 2008   History of Changes
Sponsor: University of Iowa
Collaborator: National Center for Research Resources (NCRR)
Information provided by: University of Iowa
ClinicalTrials.gov Identifier: NCT00585871
  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 Intervention
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

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • episodes of non-sustained ventricular tachycardia [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • defibrillator shocks [ Time Frame: one year ] [ Designated as safety issue: No ]

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
1: Experimental
clonidine 0.1 TID
Drug: clonidine
0.1 mg tid
2
metoprolol 25 TID
Drug: metoprolol
25 mg tid

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585871

Contacts
Contact: james b martins, md 319-356-2740 james-martins@uiowa.edu

Locations
United States, Iowa
UIHC Recruiting
Iowa City, Iowa, United States, 52242
Contact: james b martins, md     319-356-2740     james-martins@uiowa.edu    
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: james b martins, md University of Iowa
  More Information

No publications provided

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     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
implantable defibrillator treated patients with 5 episodes of ventricular tachycardia per 3 month period

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Adrenergic Agonists
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Analgesics
Tachycardia, Ventricular
Sympatholytics
Heart Diseases
Adrenergic alpha-Agonists
Tachycardia
Clonidine
Cardiovascular Agents
Metoprolol
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Adrenergic Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009