Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

NCT00585871 | Withdrawn DMC

• 2 other identifiers: 200602703study is over no ID is needed
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Keywords

ICD patients with 5 VTs per 3 month period

Outcome Measures

Primary Outcomes (1)

• episodes of non-sustained ventricular tachycardia

  one year

Secondary Outcomes (1)

• defibrillator shocks

  one year

Study Arms (2)

Clonidine therapy group

EXPERIMENTAL

clonidine 0.1 TID

Drug: clonidine

Metoprolol control group

ACTIVE COMPARATOR

metoprolol 25 TID

Drug: metoprolol

Interventions

clonidine DRUG

0.1 mg tid

Clonidine therapy group

metoprolol DRUG

25 mg tid

Metoprolol control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Implantable defibrillator treated patients with 5 episodes of ventricular tachycardia per 3 month period

You may not qualify if:

• No more than one shock/3 months
• No contraindication to clonidine
• Non-compliance
• Asthma

Sponsors & Collaborators

• James Martins: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

UIHC

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Clonidine; Metoprolol

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• james b martins, md

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2007
• First Posted: January 3, 2008
• Study Start: May 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)