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OpenTrials
Completed

NCT Number: NCT05279833

Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis, France

Chilly-Mazarin, 91380, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Following eligibility criteria are defined to select relevant studies from the literature

  • Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months]))
  • Participants have received either Dronedarone or Sotalol
  • controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies

Exclusion criteria

Exclusion criteria

for potential participants are:

  • Children/adolescents
  • Permanent atrial fibrillation (AFib)

Treatment and study plan

DRONEDARONE

Drug

Pharmaceutical form is tablet and route of administration is oral

Other names: Multaq®

Sotalol

Drug

Pharmaceutical form is tablet and route of administration is oral

Other names: BETAPACE®

Primary outcomes

  1. Number of participants with Cardiovascular (CV) hospitalization

    Time frame: As reported in studies included in the systematic review up to 10 years

    CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke

  2. Number of participants with ventricular proarrhythmia

    Time frame: As reported in studies included in the systematic review up to 10 years

  3. Number of all-cause mortality events

    Time frame: As reported in studies included in the systematic review up to 10 years

  4. Number of cardiovascular mortality events

    Time frame: As reported in studies included in the systematic review up to 10 years

    includes arrhythmia-related mortality

  5. Number of participants with atrial fibrillation (AFib) recurrence

    Time frame: As reported in studies included in the systematic review up to 10 years

Secondary outcomes

  1. Number of participants with myocardial infarction

    Time frame: As reported in studies included in the systematic review up to 10 years

  2. Number of participants with stroke

    Time frame: As reported in studies included in the systematic review up to 10 years

  3. Number of participants with heart failure hospitalization

    Time frame: As reported in studies included in the systematic review up to 10 years

  4. Number of participants with AFib hospitalization

    Time frame: As reported in studies included in the systematic review up to 10 years

  5. Number of participants with conduction disorders

    Time frame: As reported in studies included in the systematic review up to 10 years

    Atrioventricular block (2nd or 3rd degree) or Requirement of pacemaker implants

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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