The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Hartford Hospital
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
Secondary Outcomes
- 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.