NCT03289429

Brief Summary

This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus Magnesium Sulfate after Cardiac valve Replacement Surgery

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
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

September 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 24, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

September 15, 2017

Last Update Submit

February 10, 2018

Conditions

Arrhythmias

Keywords

AtorvastatinMagnesium sulfatePOAFCardiacValve

Outcome Measures

Primary Outcomes (1)

  • Postoperative atrial fibrillation

    The occurrence of postoperative atrial fibrillation (POAF)

    Five days

Study Arms (3)

Atorvastatin

EXPERIMENTAL

Atorvastatin and intravenous placebo

Drug: AtorvastatinOther: intravenous placebo

Magnesium sulfate

EXPERIMENTAL

Magnesium sulfate and tablets placebo

Drug: Magnesium SulfateOther: tablets placebo

Control

PLACEBO COMPARATOR

intravenous placebo and tablet placebo

Other: intravenous placeboOther: tablets placebo

Interventions

AtorvastatinDRUG

Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.

Atorvastatin
Magnesium SulfateDRUG

Magnesium sulfate: ( 3 grams dissolved in 100 mL of isotonic saline to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.

Magnesium sulfate
intravenous placeboOTHER

100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.

AtorvastatinControl
tablets placeboOTHER

Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.

ControlMagnesium sulfate

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing isolated valvular replacement surgery.
  • Preoperative rhythm: Sinus rhythm.
  • Preoperative troponin I \< 0.01 ng/mL.
  • Normal lipid profile.
  • White blood cells (4-11 X 103/mm3).
  • Preoperative C-reactive protein \< 3 mg/L.

You may not qualify if:

  • History of atrial fibrillation.
  • Any degree of heart block or patients with implanted pacemaker.
  • Prior use of Antiarrhythmic drugs.
  • Preoperative lipid lowering therapy (e.g statins) during the last 3 months.
  • Previous treatment with any type of magnesium containing supplementation (the week before the intervention).
  • Underlying heart failure or Left ventricular ejection fraction \< 0.3.
  • Previous myocardial infarction.
  • Diabetes or other metabolic disorders.
  • Renal diseases.
  • Hepatic dysfunction.
  • Underlying thyroid problems (hypo/hyperthyroidism).
  • Underlying inflammatory disease (active or controlled)
  • Immunosuppressive and anti-inflammatory medications for the treatment of coexisting conditions.
  • Psychological disorders,
  • Emergency cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

AtorvastatinMagnesium Sulfate

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of anesthesia and intensive care, Assiut University

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 21, 2017

Study Start

September 24, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

EG(1)