Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation

NCT01070667 | Unknown Phase 4

• 1 other identifier: DROPPAF V2.1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compared with placebo. This has never previously been performed using pacemaker Holter monitoring which provides detailed information of atrial arrhythmia patterns the entire study period. Additionally detailed patient symptom self assessment and questionnaires will be collected. The study design will be double blinded crossover with each phase lasting 3 months.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

PAF; AF; Dronedarone; AF Burden; AFB; PPM; Permanent Pacemaker; Atrial Fibrillation Burden in Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• To accurately assess, by the use of long term beat to beat pacemaker Holter monitoring, the effect of of dronedarone upon AF burden.

  3 months

Secondary Outcomes (4)

• To accurately assess the number of AF episodes, AF frequency and average duration of sinus rhythm.

  3 months

• To assess differences in patient experience of dronedarone and placebo therapies by means of questionnaires.

  3 months

• Quality of life measures - SF-36, visual analogue scores, symptom assessment scores.

  3 months

• Comparison of side effects and major adverse cardiac events.

  3 months

Study Arms (2)

Dronedarone

EXPERIMENTAL

Patients will receive 400 mg of dronedarone per day for 3 months.

Drug: Dronedarone

Placebo

PLACEBO COMPARATOR

Patients will receive a placebo tablet once per day for 3 months. AF burden and other parameters described will be monitored from the participants permanent pacemaker. Participants will also be asked to fill out symptom diaries and questionaires.

Drug: Placebo

Interventions

Dronedarone DRUG

400mg orally once per day for 3 months

Also known as: Multaq

Dronedarone

Placebo DRUG

1 tablet once per day for 3 months. The tablet will appear identical to the active dronedarone tablet.

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with paroxysmal atrial fibrillation (AF burden 1-50% as defined by DDDRP PPM) during the 3 months prior to induction to the study.
• Patients who have had DDDRP pacemaker implanted for a primary or secondary indication.
• Patients must be on warfarin.
• Patients must be over 18 years old.
• Patients give informed consent form prior to participating in this study.

You may not qualify if:

• Current or previous treatment with amiodarone.
• Patient is suffering with unstable angina in last 1 week.
• Patient has had a myocardial infarction within last 2 months.
• Patient is expecting or has had major cardiac surgery within last 2 months.
• Patient is participating in a conflicting study.
• Patient is mentally incapacitated and cannot consent or comply with follow-up.
• Patient has NYHA class III/ IV heart failure.
• Pregnancy.
• Patient suffers with other cardiac rhythm disorders.
• Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
• GFR \< 30mls/min.

Sponsors & Collaborators

• Eastbourne General Hospital: lead

Study Sites (1)

Eastbourne DGH

Eastbourne, East Sussex, BN21 2UD, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amiodarone; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• A N Sulke, MD

  East Sussex NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven J Podd, MA, MBBS

CONTACT

01323417400; steven.podd@esht.nhs.uk

A N Sulke, MD

CONTACT

01323417400; pamela.morley@esht.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 22, 2010

Record last verified: 2010-02

Locations

GB (1)