Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Recruitment status was Recruiting
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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 |
- episodes of non-sustained ventricular tachycardia [ Time Frame: one year ] [ Designated as safety issue: No ]
- defibrillator shocks [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | January 2012 |
| Estimated 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
|
|
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 |
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| Contact: james b martins, md | 319-356-2740 | james-martins@uiowa.edu |
| United States, Iowa | |
| UIHC | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: james b martins, md 319-356-2740 james-martins@uiowa.edu | |
| 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 First Received: | December 29, 2007 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
ICD treated patients with 5 episodes of VT per 3 month period |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Anti-Arrhythmia Agents Heart Diseases Cardiovascular Diseases Pathologic Processes Metoprolol Clonidine Metoprolol succinate Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Sympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Analgesics Sensory System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013