NCT00282659

Brief Summary

The purpose of this study is to determine if magnesium can improve blood pressure, cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators (ICDs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

2.4 years

First QC Date

January 25, 2006

Last Update Submit

May 17, 2019

Conditions

Coronary Artery DiseaseHypertensionDyslipidemiaDiabetes

Keywords

HemodynamicsHypertensionDyslipidemiaDiabetesImplantable Cardioverter DefibrillatorBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure, cardiac output, systemic vascular resistance, thoracic fluid content, total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, and blood glucose

    at baseline, 3, and 6 months of follow-up

Interventions

magnesium L-lactateDRUG

Eligibility Criteria

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

You may qualify if:

  • Newly implanted ICD or recent ICD shock (within 6 months)

You may not qualify if:

  • Inability to swallow
  • A non-cardiac disease with a survival prognosis of less than 12 months
  • Hypermagnesemia
  • Creatinine clearance less than 30mL/min
  • Lactic acidosis or systemic acidosis syndrome
  • Previous intolerance to magnesium L-lactate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHypertensionDyslipidemiasDiabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Charles M White, PharmD

    University of Connecticut School of Pharmacy, Hartford Hospital Division of Drug Information

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

January 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

US(1)