Rate Control Efficacy in permanent atrial fibrillation, a comparison between lenient verus strict rate control in patients with and without heart failure.

Recruiting

Registration Number: NL-OMON29392

Lead Sponsor: etherlands Heart FoundationInteruniversity Cardioly Institute the NetherlandsAstraZenecaAventis SanofiBiotronikGuidantMedtronicRocheVitatron

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

1. Patients with persistent AF < 12 months;
2. Age < 80 years;
3. Resting heart rate > 80 beats per minute;
4. On oral anticoagulation.

Exclusion Criteria

1. Paroxysmal AF;
2. Known contraindications for strict or lenient rate control;
3. Unstable heart failure;
4. Cardiac surgery.
5. Any current stroke;
6. Foreseen pacemaker or cardiac resynchronization therapy;
7. Sick sinus syndrome or AV node conduction disturbances;
8. Untreated hyperthyroidism;
9. Inability to walk or bike.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Component of: cardiovascular mortality, heart failure, stroke, systemic emboli, bleeding, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, life-threatening adverse effects of rate control drugs, pacemaker implantation.

Secondary Outcome Measures

Name	Time	Method
1. All casue mortality;<br>2. All cause hospitalizations;<br>3. Exercise tolerance (NYHA class);<br>4. Left ventricular function;<br>5. Left atrial size;<br>6. Quality of life;<br>7. NT-proBNP;<br>8. Hospitalization for heart failure;<br>9. Syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations;<br>10. Bleeding, any stroke, systemic emboli;<br>11. Myocardial infarction confirmed by ECG and enzyme increase;<br>12. Costs;<br>13. Renal function.