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Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.

Hartford Hospital logo

Hartford Hospital

Status and phase

Unknown
Phase 4

Conditions

Arrhythmia
Quality of Life
Hypomagnesemia

Treatments

Drug: Magnesium L-lactate

Study type

Interventional

Funder types

Other

Identifiers

NCT00282620
KLUG001817HE

Details and patient eligibility

About

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.

Full description

Not all ICD shocks are for ventricular arrhythmias. Some patients receive shocks when they have arrhythmias in the atria (top chambers of the heart). These are called inapproriate shocks, but the pain is similar to the pain patients feel with an appropriate shock (a shock for a ventricular arrhythmia). This study is being conducted to determine if taking magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life. Magnesium's impact of the electrocardiogram (ECG) and intracellular magnesium concentrations will also be studied.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the number of ICD shocks and patient perceived quality of life.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Charles M White, PharmD; Jeffrey Kluger, MD

Data sourced from clinicaltrials.gov

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