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Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00585871
Enrollment
0
Registered
2008-01-03
Start date
2006-05-31
Completion date
2012-01-31
Last updated
2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Tachycardia

Keywords

ICD patients with 5 VTs per 3 month period

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.

Interventions

DRUGclonidine

0.1 mg tid

DRUGmetoprolol

25 mg tid

Sponsors

National Center for Research Resources (NCRR)
CollaboratorNIH
James Martins
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frame
episodes of non-sustained ventricular tachycardiaone year

Secondary

MeasureTime frame
defibrillator shocksone year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026