Recruiting

Magnesium

Sponsor:

Hartford Hospital

Code:

NCT00282620

Conditions

Arrhythmia

Quality of Life

Hypomagnesemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnesium L-lactate

Study Details

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.

Conditions

Arrhythmia

Quality of Life

Hypomagnesemia

Study ID

NCT00282620

Start date

Jan, 2006

Status verified date

Mar, 2007

Completion date

Jun, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:newly implanted ICD or recent ICD shock (within 6 months) -

Exclusion Criteria:inability to swallow, a non-cardiac disease with a survival prognosis of less than 12 months, hypermagnesemia, a creatinine clearance less than 30mL/min, lactic acidosis or systemic acidosis syndrome, or previous intolerance to magnesium L-lactate.

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Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Magnesium L-lactate

Primary outcome measure

  • Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Jeffrey Kluger, MD

860-545-2883Jkluger@harthosp.org

Charles M White, PharmD

860-545-2221Cmwhite@harthosp.org

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102-5037

Contacts

Jeffrey Kluger, MD

860-545-2883JKluger@harthosp.org

Charles M White, PharmD

860-545-2221Cmwhite@harthosp.org

Principal Investigator:

Jeffrey Kluger, MD

More Information

Sponsor

Hartford Hospital

Last update posted

Nov 20, 2007

Last verified

Mar, 2007

Keywords

  • Implantable Cardioverter Defibrillator
  • Magnesium
  • Electrocardiogram
  • Ventricular Arrhythmia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2007-11-20.