Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers

NCT00225667 | Unknown Phase 3

• 2 other identifiers: 099104CTA-099104
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker.

Conditions

Atrial Fibrillation; Hypertension

Keywords

Atrial Fibrillation; Arrhythmia; Pacemaker, Artificial; Atrial High Rate Episodes; Electrophysiology; Renin-Angiotensin System; Hypertension; Cardiac Remodeling

Outcome Measures

Primary Outcomes (1)

• Time to recurrent AHRE ( 220/min for > 2 minutes)

Secondary Outcomes (9)

• - Frequency of AHRE's (> 220/min for > 2 minutes) Evaluated at randomization, month 1 and 6.

• - Development of sustained AF (>30 minutes), documented

• by ECG, holter, rhythm strip or pacemaker electrograms

• - Electrical Remodeling (AERP,SNRT,paced/sensed p-wave

• duration). Evaluated at randomization, months 1 and 6.

Interventions

Irbesartan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sinus Node Dysfunction (with or without AV conduction disturbance)
• Permanent, atrial or dual-chamber pacemaker implanted \> 2 months before enrollment and with ability to record and store atrial high-rate episodes, frequency of mode switches and to perform non-invasive electrophysiologic testing
• History of at least 6 AHRE in the last 6 months (rate \> 220/min, duration of \> 2 minutes
• History of prior diagnosis of hypertension and/or treated for hypertension OR two documented BP \> 130/85 (measurements done at least one week apart)

You may not qualify if:

• Permanent or persistent AF or more than 6 episodes of symptomatic paroxysmal AF in the previous 6 months
• Documented Cr \>200 umol/L and K+ \>5.2 mmol/L in the previous 3 months
• Current treatment with a potassium sparing diuretic, unless serum potassium known to be in the normal range
• LV ejection fraction known to be \< 40 %
• Moderate or severe mitral regurgitation (3+, 4 +)
• Mitral stenosis of more than mild severity
• Aortic stenosis with mean gradient of \> 25 mmHg
• Angina at rest in the last 2 months, or current CCS Class 3 or 4 angina
• Unipolar atrial lead
• Previous AV node ablation
• P-wave amplitude less than 1.5 mV
• Current therapy with an ACE inhibitor, ARB or aldosterone antagonist
• Current or planned (within 6 months) with an anti-arrhythmic medication (amiodarone, sotalol, flecainide, propafenone, quinidine, dofetilide

Sponsors & Collaborators

• Connolly, Stuart, M.D.: lead
• Sanofi: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Population Health Research Institute of McMaster University

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension; Arrhythmias, Cardiac

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Stuart J. Connolly, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jeffrey S Healey, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Carlos A Morillo, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Stefan H Hohnloser, MD

  J.W. Goethe University, Frankfurt Germany

  PRINCIPAL INVESTIGATOR

• Carsten W Israel, MD

  J.W. Goethe University, Frankfurt Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart J. Connolly, MD

CONTACT

905-527-4322; connostu@hhsc.ca

Jeffrey S. Healey, MD

CONTACT

905-527-4322; healeyj@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 26, 2005
• Study Start: December 1, 2005
• Study Completion: July 1, 2007
• Last Updated: November 23, 2005

Record last verified: 2005-11

Locations

CA (1)