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Atrial FibrillationPhase 4HESTIANCT01135017

Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

A Phase 4 study testing Dronedarone in people with Atrial Fibrillation, run by Sanofi at 92 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker. Secondary objectives were to evaluate: the effects of dronedarone on AF pattern characteristics i.e. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Dronedarone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
92 sitesUnited States
Study dates
Jul 2010to Feb 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Paroxysmal AF or atrial flutter (AFL) documented by evidence of AF/AFL and sinus rhythm within the prior 6 months;
  • AF burden ≥1% on pacemaker EGM interrogation at screening, with at least one episode of AF within the previous 28 days;
  • Programmable dual chamber pacemaker with lead placement no less than 3 months before screening, a minimum capability of storing 3 months or more of EGM data, and an expected remaining battery life of 1 year or more.

Who cannot join

  • AF burden <1% on pacemaker EGM interrogation at screening;
  • None of the following cardiovascular risk factors: Age ≥70 years, hypertension, diabetes mellitus, prior cardiovascular accident or systemic embolism, left atrium diameter ≥50 mm by M-mode or 2D echocardiography, or left ventricular ejection fraction ≤0.40 by M-mode or 2D echocardiography, cardiac catheterization, or nuclear cardiac imaging;
  • Permanent AF;
  • Evidence of persistent AF (continuous AF activity lasting longer than 7 days);
  • Electrical cardioversion (or overdrive pacing) within 4 weeks prior to screening;
  • Cardiac ablation procedure within 3 months prior to screening;
Show all 27Show fewer
  • Evidence of uncorrected atrial undersensing or oversensing documented in routine pacemaker evaluation at screening;
  • Pacemaker programming requirements for the study not clinically feasible, contraindicated, or could have posed risk;
  • Ongoing potentially dangerous symptoms when in AF/AFL such as angina pectoris, transient ischemic attacks, stroke, or syncope;
  • New York Heart Association (NYHA) Class IV heart failure or NYHA Class II or III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic within 4 weeks prior to screening;
  • Evidence of clinical instability including hypotension, unstable angina and hemodynamically significant obstructive valvular disease, hemodynamically significant obstructive cardiomyopathy, a cardiac operation, or revascularization procedure within 4 weeks prior to screening;
  • Noncardiovascular illness or disorder that could have precluded participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression;
  • Planned noncardiac or cardiac surgery or procedures including surgery for valvular heart disease, coronary artery bypass graft, percutaneous coronary intervention, cardiac transplantation or electrical cardioversion for AF/AFL;
  • Need for concomitant medication that were prohibited in this trial: Antiarrhythmics, drugs or products that are strong inhibitors of CYP3A, CYP3A inducers;
  • Chronic use of amiodarone within the 4 weeks prior to screening;
  • Use of Class I or Class III antiarrhythmics (other than amiodarone) within 5-half lives prior to screening;
  • Use of St John's wort, grapefruit juice, or drugs that prolong the QT interval and might have increased the risk of torsade de pointes;
  • Inability or unwillingness to comply with oral anticoagulation therapy, if indicated;
  • Bazett corrected QT interval interval ≥500 msec at screening (if in sinus rhythm);
  • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100mmHg) at screening;
  • Uncorrected hypokalemia (serum potassium <3.5 mEq/L)
  • Severe hepatic impairment (ie, Child-Pugh Class C), abnormal liver function test defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin >2 X upper limit of normal (ULN), or renal impairment defined as serum creatinine >2.0 mg/dL at screening;
  • Uncontrolled diabetes mellitus (documented history of HbA1c >10% at the most recent assessment prior to screening);
  • Pregnant woman or woman of childbearing potential not on adequate birth control;
  • Breastfeeding woman;
  • Previous (within 2 months prior to screening) or current participation in another clinical trial with an investigational drug (under development) or investigational device.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • Investigational Site Number 840001

    Aurora, Colorado, 80012

  • Investigational Site Number 840121

    Beverly Hills, California, 90211

  • Investigational Site Number 840015

    Birmingham, Alabama, 35235

  • Investigational Site Number 840051

    Bloomington, Indiana, 47403

  • Investigational Site Number 840026

    Bridgewater, New Jersey, 08807

  • Investigational Site Number 840006

    Buffalo, New York, 14215

  • Investigational Site Number 840008

    Camp Hill, Pennsylvania, 17011

  • Investigational Site Number 840010

    Clearwater, Florida, 33756

  • Investigational Site Number 840102

    Columbia, Maryland, 21044

  • Investigational Site Number 840037

    Columbia, Missouri, 65212

  • Investigational Site Number 840118

    Corpus Christi, Texas, 78404

  • Investigational Site Number 840014

    Dallas, Texas, 75390-8858

  • Investigational Site Number 840113

    Danville, Virginia, 24541

  • Investigational Site Number 840009

    Doylestown, Pennsylvania, 18901

  • Investigational Site Number 840093

    Englewood, New Jersey, 07631

  • Investigational Site Number 840020

    Fort Myers, Florida, 33908

  • Investigational Site Number 840056

    Gainesville, Georgia, 30501

  • Investigational Site Number 840114

    Germantown, Tennessee, 38138

  • Investigational Site Number 840123

    Green Bay, Wisconsin, 54301-3505

  • Investigational Site Number 840119

    Greenville, South Carolina, 29607

  • Investigational Site Number 840069

    Hot Springs, Arkansas, 71913

  • Investigational Site Number 840087

    Huntsville, Alabama, 35801

  • Investigational Site Number 840058

    Inverness, Florida, 34452

  • Investigational Site Number 840043

    Jacksonville, Florida, 32204

  • Investigational Site Number 840066

    Jacksonville, Florida, 32216

  • Investigational Site Number 840128

    Jacksonville, Florida, 32216

  • Investigational Site Number 840044

    Jacksonville Beach, Florida, 32250

  • Investigational Site Number 840053

    Kansas City, Kansas, 66160

  • Investigational Site Number 840035

    Kansas City, Missouri, 64111

  • Investigational Site Number 840077

    Kingston, New York, 12401

  • Investigational Site Number 840090

    Laguna Hills, California, 92653

  • Investigational Site Number 840017

    Lansing, Michigan, 48910

  • Investigational Site Number 840081

    Lapeer, Michigan, 48446

  • Investigational Site Number 840089

    Littleton, Colorado, 80120

  • Investigational Site Number 840068

    Los Angeles, California, 90048

  • Investigational Site Number 840029

    Loveland, Colorado, 80538

  • Investigational Site Number 840082

    Lynchburg, Virginia, 24501

  • Investigational Site Number 840022

    Madison, Wisconsin, 53713

  • Investigational Site Number 840088

    Manassas, Virginia, 20109

  • Investigational Site Number 840030

    Mesa, Arizona, 85206

  • Investigational Site Number 840033

    Milwaukee, Wisconsin, 53215

  • Investigational Site Number 840047

    Milwaukee, Wisconsin, 53215

  • Investigational Site Number 840076

    Milwaukee, Wisconsin, 53226

  • Investigational Site Number 840096

    Mineola, New York, 11501

  • Investigational Site Number 840062

    Mission Hills, California, 91345

  • Investigational Site Number 840067

    Missoula, Montana, 59802

  • Investigational Site Number 840018

    Mobile, Alabama, 36608

  • Investigational Site Number 840108

    Newark, Delaware, 19713

  • Investigational Site Number 840092

    Normal, Illinois, 61761

  • Investigational Site Number 840032

    Oak Lawn, Illinois, 60453

  • Investigational Site Number 840070

    Orange, California, 92868

  • Investigational Site Number 840042

    Orlando, Florida, 32803

  • Investigational Site Number 840110

    Owensboro, Kentucky, 42303

  • Investigational Site Number 840075

    Petoskey, Michigan, 49770

  • Investigational Site Number 840004

    Philadelphia, Pennsylvania, 19111

  • Investigational Site Number 840048

    Phoenix, Arizona, 85006

  • Investigational Site Number 840072

    Phoenix, Arizona, 85032

  • Investigational Site Number 840078

    Phoenixville, Pennsylvania, 19460

  • Investigational Site Number 840105

    Pittsburgh, Pennsylvania, 15236

  • Investigational Site Number 840016

    Port Charlotte, Florida, 33952

  • Investigational Site Number 840084

    Raleigh, North Carolina, 27610

  • Investigational Site Number 840002

    Rapid City, South Dakota, 57701

  • Investigational Site Number 840049

    Reno, Nevada, 89502

  • Investigational Site Number 840054

    Reno, Nevada, 89502

  • Investigational Site Number 840099

    Richmond, Virginia, 23219

  • Investigational Site Number 840112

    Richmond, Virginia, 23230

  • Investigational Site Number 840021

    Riverside, California, 92501

  • Investigational Site Number 840046

    Rockford, Illinois, 61107

  • Investigational Site Number 840104

    Saint Cloud, Minnesota, 56301

  • Investigational Site Number 840083

    Salt Lake City, Utah, 84102

  • Investigational Site Number 840012

    San Antonio, Texas, 78229

  • Investigational Site Number 840024

    San Diego, California, 92103

  • Investigational Site Number 840130

    Scranton, Pennsylvania, 18510

  • Investigational Site Number 840060

    St Louis, Missouri, 63122

  • Investigational Site Number 840055

    St Louis, Missouri, 63141

  • Investigational Site Number 840041

    Syracuse, New York, 13202

  • Investigational Site Number 840003

    Tacoma, Washington, 98405

  • Investigational Site Number 840107

    Tacoma, Washington, 98405

  • Investigational Site Number 840036

    The Bronx, New York, 10467

  • Investigational Site Number 840027

    Troy, Michigan, 48085

  • Investigational Site Number 840086

    Troy, New York, 12180

  • Investigational Site Number 840013

    Tucson, Arizona, 85723

  • Investigational Site Number 840065

    Tulsa, Oklahoma, 74104

  • Investigational Site Number 840097

    Tupelo, Mississippi, 38801

  • Investigational Site Number 840125

    Tyler, Texas, 75701

  • Investigational Site Number 840019

    Unionville, Pennsylvania, 15401

  • Investigational Site Number 840045

    Washington D.C., District of Columbia, 20010-2975

  • Investigational Site Number 840106

    Washington D.C., District of Columbia, 20037

  • Investigational Site Number 840080

    Wellington, Florida, 33449

  • Investigational Site Number 840007

    Williamsville, New York, 14221

  • Investigational Site Number 840061

    Wilmington, North Carolina, 28401

  • Investigational Site Number 840023

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Dronedarone 400 mg BID for 12 Weeks on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker.

Secondary objectives were to evaluate:

  • the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF;
  • the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS);
  • the incidence of electrical cardioversion (or overdrive pacing) during treatment;
  • the safety of dronedarone.
Read the detailed description

The maximum duration of the study period for a participant was 18 weeks (approximatively 4.5 months) including up to 4 weeks screening, 12-week Treatment period and a post-treatment follow-up of 2 weeks.

Being tested
Dronedarone, Placebo (for Dronedarone)
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DronedaroneDrug

    Also called Multaq®, SR33589

    Film-coated tablet

    Oral administration under fed conditions (during breakfast and dinner)

  • Placebo (for Dronedarone)Drug

    Film-coated tablet strictly identical in appearance

    Oral administration under fed conditions (during breakfast and dinner)

Study groups in NCT01135017
Study groupRoleWhat they receive
DronedaroneExperimentalDronedarone 400 mg twice a day for 12 weeks
Receives: Drug: Dronedarone
PlaceboPlacebo comparatorPlacebo (for Dronedarone) twice a day for 12 weeks
Receives: Drug: Placebo (for Dronedarone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atrial Fibrillation (AF) Burden During the 12-week Treatment Period

    AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator.

    AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.

    Measured: Baseline (before randomization), 4 weeks and 12 weeks after randomization

Secondary outcomes (4)

  1. AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment

    AF burden at each pacemaker interrogation as evaluated centrally by the Pacemaker Core Lab

    Measured: 4 weeks and 12 weeks after randomization

  2. Average Ventricular Rate During AF Episodes

    Ventricular rates of AF episodes were obtained from pacemaker interrogation and EGM review.

    The average ventricular rate during AF episodes in the 12-week treatment period was defined as the duration-weighted average of the ventricular rates collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.

    Measured: Baseline (before randomization), 4 weeks and 12 weeks after randomization

  3. Atrial Fibrillation Severity Scale (AFSS) Scores

    The University of Toronto Atrial Fibrillation Severity Scale is an instrument to assess the subject-perceived AF burden and AF symptom severity. It consists in a questionnaire plus a scoring algorithm.

    AF Burden score ranges from 3 to 30 and higher scores indicate greater AF burden.

    AF symptoms severity score ranges from 0 to 35 and higher scores indicate extremely severe AF symptoms.

    Measured: Baseline (before randomization) and 12 weeks after randomization

  4. Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)

    Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias.

    Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01135017
Sponsor's protocol ID
DRONE_L_04316
Other IDs
U1111-1117-0024
Acronym
HESTIA
Status last verified
Apr 2013
First submitted
28 May 2010
Last updated
11 Apr 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dronedarone in people with Atrial Fibrillation, run by Sanofi at 92 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial Fibrillation (AF) Burden During the 12-week Treatment Period (time frame: Baseline (before randomization), 4 weeks and 12 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01135017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.

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