Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

NCT ID: NCT00585871

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2012-01-31

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.

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clonidine therapy group

clonidine 0.1 TID

Group Type: EXPERIMENTAL

clonidine

Intervention Type: DRUG

0.1 mg tid

Metoprolol control group

metoprolol 25 TID

Group Type: ACTIVE_COMPARATOR

metoprolol

Intervention Type: DRUG

25 mg tid

Interventions

clonidine

0.1 mg tid

Intervention Type: DRUG

metoprolol

25 mg tid

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

James Martins

OTHER

Sponsor Role: lead

Responsible Party

James Martins

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

james b martins, md

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

UIHC

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

study is over no ID is needed

Identifier Type: -

Identifier Source: secondary_id

200602703

Identifier Type: -

Identifier Source: org_study_id