Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Primary Purpose
Ventricular Tachycardia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
clonidine
metoprolol
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring ICD patients with 5 VTs per 3 month period
Eligibility 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
Sites / Locations
- UIHC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clonidine therapy group
Metoprolol control group
Arm Description
clonidine 0.1 TID
metoprolol 25 TID
Outcomes
Primary Outcome Measures
episodes of non-sustained ventricular tachycardia
Secondary Outcome Measures
defibrillator shocks
Full Information
NCT ID
NCT00585871
First Posted
December 29, 2007
Last Updated
July 20, 2018
Sponsor
James Martins
Collaborators
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00585871
Brief Title
Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Official Title
Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
could not recruit
Study Start Date
May 2006 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Martins
Collaborators
National Center for Research Resources (NCRR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
ICD patients with 5 VTs per 3 month period
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clonidine therapy group
Arm Type
Experimental
Arm Description
clonidine 0.1 TID
Arm Title
Metoprolol control group
Arm Type
Active Comparator
Arm Description
metoprolol 25 TID
Intervention Type
Drug
Intervention Name(s)
clonidine
Intervention Description
0.1 mg tid
Intervention Type
Drug
Intervention Name(s)
metoprolol
Intervention Description
25 mg tid
Primary Outcome Measure Information:
Title
episodes of non-sustained ventricular tachycardia
Time Frame
one year
Secondary Outcome Measure Information:
Title
defibrillator shocks
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
james b martins, md
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
UIHC
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
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