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Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

This study is currently recruiting participants.
Verified by University of Iowa, December 2007

Sponsors and Collaborators: University of Iowa
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

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

MedlinePlus related topics:   Pacemakers and Implantable Defibrillators   

Drug Information available for:   Metoprolol    Metoprolol fumarate    Metoprolol succinate    Metoprolol Tartrate    Clonidine    Clonidine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:   Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

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

Investigators
Principal Investigator:     james b martins, md     University of Iowa    
  More Information


Responsible Party:   General Clinical Research Center ( James Martins, MD )
Study ID Numbers:   200602703
First Received:   December 29, 2007
Last Updated:   January 2, 2008
ClinicalTrials.gov Identifier:   NCT00585871
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  

Study placed in the following topic categories:
Heart Diseases
Metoprolol succinate
Tachycardia
Clonidine
Metoprolol
Tachycardia, Ventricular
Arrhythmias, Cardiac

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 30, 2008




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