Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

This study has been terminated.
(could not recruit)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Martins, University of Iowa
ClinicalTrials.gov Identifier:
NCT00585871
First received: December 29, 2007
Last updated: December 9, 2013
Last verified: August 2013
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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 ]

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585871

Locations
United States, Iowa
UIHC
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: james b martins, md University of Iowa
  More Information

No publications provided

Responsible Party: James Martins, Professor, University of Iowa
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Clonidine
Metoprolol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
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

ClinicalTrials.gov processed this record on October 19, 2014