Hydroquinidine Versus Placebo in Patients With Brugada Syndrome

NCT00927732 | Terminated Phase 3 DMC

• 1 other identifier: 06/2-D
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 17

Brief Summary

The specific aim of this study is to determine whether hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable defibrillator (ICD).

Conditions

Brugada Syndrome

Keywords

Brugada; hydroquinidine; ventricular arrhythmia; patients with Brugada syndrome, high cardiac arrhythmic risk and implanted with an implantable cardioverter defibrillator

Outcome Measures

Primary Outcomes (1)

• To determine whether hydroquinidine enhances time length before arisen of an appropriate shock registered on the automatic implantable defibrillator (meaning due to ventricular arrhythmia)

  3 years after patient randomization

Secondary Outcomes (5)

• To evaluate number and frequency of inappropriate shock with and without hydroquinidine

  3 years after patient randomization

• To evaluate the number of tachycardia or of ventricular fibrillations detected by the defibrillator but not having required any treatment

  3 years after patient randomization

• To evaluate number of syncope reported by the patient but for which no ventricular arrhythmias has been detected by the defibrillator

  3 years after patient randomization

• To evaluate the number and frequency of adverse events appeared under hydroquinidine treatment

  3 years after patient randomization

• To evaluate interest of the electrophysiological exploration for determining chances of success of an hydroquinidine

  3 years after patient randomization

Study Arms (2)

hydroquinidine

EXPERIMENTAL

As it is a cross-over study, patient will taken treatment 1 for 18 months (ex: hydroquinidine) and then treatment 2 (placebo in this case) for 18 months.

Drug: hydroquinidine

capsules of sugar

PLACEBO COMPARATOR

As it is a cross-over study, patient will taken treatment 1 for 18 months (ex: hydroquinidine) and then treatment 2 (placebo in this case) for 18 months.

Drug: placebo (sugar)

Interventions

hydroquinidine DRUG

capsules of 300 mg LP, 1 or 2 or 3 times per day : frequency will be determined by tests after patient inclusion before her/his randomization

Also known as: Hydroquinidine is commercialized as Serecor

hydroquinidine

placebo (sugar) DRUG

capsules of placebo have same design and color than capsules of hydroquinidine except for their content as they contain sugar and not hydroquinidine

capsules of sugar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult (at least 18 years of age)
• Informed consent form signed
• Subject affiliated to French health insurance (Sécurité Sociale)
• Type 1 Brugada syndrome either symptomatic or asymptomatic
• Not pregnant, taking oral contraceptive measure if able to procreate
• No current intake of "betablocking" medicine used in cardiac insufficiency (bisoprolol, carvedilol, metoprolol)
• No current myasthenia
• No current treatment with halofantrine, pentamidine, moxifloxacin
• No current treatment with some neuroleptics
• Known hypersensitivity to hydroquinidine
• Intolerance to fructose, syndrome of glucose or galactose malabsorption, deficit in sucrase isomaltase- Cardiac insufficiency
• Histories of "torsades de pointe"
• Intake of medicine giving "torsades de pointe"

You may not qualify if:

• Subject being before study entry under hydroquinidine treatment but either at a dose \> 3 capsules per day or at a dose of 1, 2 or 3 capsules per day but with a plasmatic hydroquinidine concentration \>6µmol/L or \<3 µmol/L

Sponsors & Collaborators

• Nantes University Hospital: lead
• Sanofi: collaborator

Study Sites (17)

CHU Amiens

Amiens, 80, France

Location

CHU Angers

Angers, 49, France

Location

CHU Bordeaux

Bordeaux, 33, France

Location

CHU Brest

Brest, 29, France

Location

CHU Grenoble

Grenoble, 38, France

Location

CHRU Lille

Lille, 59, France

Location

CHU Lyon

Lyon, 69, France

Location

AP-HM Marseille

Marseille, 13, France

Location

CHU Montpellier

Montpellier, 34, France

Location

CHU Nancy

Nancy, 54, France

Location

CHU Nantes

Nantes, 44093, France

Location

AP-HP Paris Lariboisière

Paris, 75, France

Location

CHU Poitiers

Poitiers, 86, France

Location

CHU Rennes

Rennes, 35, France

Location

CHU Strasbourg

Strasbourg, 67, France

Location

CHU Toulouse

Toulouse, 31, France

Location

CHU Tours

Tours, 37, France

Location

MeSH Terms

Conditions

Brugada Syndrome

Interventions

hydroquinidine; Sugars

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• V Probst, Pr

  CHU NANTES - Hôpital Laennec

  PRINCIPAL INVESTIGATOR

• JM Dupuis, Dr

  University Hospital, Angers

  STUDY CHAIR

• JS Hermida, Pr

  CHU AMIENS

  STUDY CHAIR

• M Haissaguerre, Pr

  University Hospital, Bordeaux

  STUDY CHAIR

• J Mansourati, Pr

  CHU BREST

  STUDY CHAIR

• P Defaye, Dr

  University Hospital, Grenoble

  STUDY CHAIR

• S Kacet, Pr

  CHRU LILLE

  STUDY CHAIR

• P Chevallier, Pr

  Hospices Civils de Lyon

  STUDY CHAIR

• JC Deharo, pr

  CHU MARSEILLE

  STUDY CHAIR

• JM Davy, Pr

  University Hospital, Montpellier

  STUDY CHAIR

• N Sadoul, Pr

  CHU NANCY

  STUDY CHAIR

• A Leenhardt, Pr

  CHU PARIS LARIBOISIERE

  STUDY CHAIR

• A Amiel, Dr

  CHU Poitiers

  STUDY CHAIR

• P Mabo, Pr

  CHU Rennes

  STUDY CHAIR

• M Chauvin, Pr

  CHU STRASBOURG

  STUDY CHAIR

• D Babuty, Pr

  CHU Tours

  STUDY CHAIR

• P Maury, Dr

  University Hospital, Toulouse

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

FR (17)