NCT00282620

Brief Summary

This study is being conducted to see if magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 20, 2007

Status Verified

March 1, 2007

First QC Date

January 25, 2006

Last Update Submit

November 16, 2007

Conditions

ArrhythmiaQuality of LifeHypomagnesemia

Keywords

Implantable Cardioverter DefibrillatorMagnesiumElectrocardiogramVentricular Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months

Secondary Outcomes (5)

  • Change in QTc interval in the total population and the subgroup receiving class III antiarrhythmics at baseline, 3, 6, 9, 12 months.

  • Intracellular magnesium concentrations at baseline, 3 and 12 months

  • Incidence of supraventricular arrhythmias, ventricular arrhythmias, and sinus tachycardias at baseline, 3,6,9,12 months.

  • Ventricular fibrillation cycle length and the variability in VFCL at baseline, 3,6,9,12 months

  • Adverse events at basline, 3,6,9,12 months. Total Hospital Costs and Cost-effectiveness.

Interventions

Magnesium L-lactateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey Kluger, MD

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Kluger, MD

CONTACT

860-545-2883Jkluger@harthosp.org

Charles M White, PharmD

CONTACT

860-545-2221Cmwhite@harthosp.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

January 1, 2006

Study Completion

June 1, 2008

Last Updated

November 20, 2007

Record last verified: 2007-03

Locations

US(1)