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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29392

Enrollment

500

Registered

2005-09-25

Start date

2005-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

1. Lenient rate control (heart rate in rest < 110 bpm)

2. Strict rate control: heart rate in rest < 80 bpm and during minor exercise < 110 bpm.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with persistent AF 80 beats per minute; 4. On oral anticoagulation.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Contacts

Public ContactIsabelle C. Gelder, van

University Medical Center Groningen (UMCG), P.O. Box 30001

i.c.van.gelder@thorax.umcg.nl+31 (0)50 3611327

Outcome results