Lenient rate control is not inferior to strict rate control in patients with permanent atrial fibrillation with and without heart failure in terms of cardiovascular mortality and morbidity, neurohormonal activation, NYHA class for heart failure,…
Bron
Verkorte titel
Ondersteuning
Interuniversity Cardioly Institute the Netherlands
AstraZeneca
Aventis Sanofi
Biotronik
Guidant
Medtronic
Roche
Vitatron
Interuniversity Cardioly Institute the Netherlands
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Rate control may now be adopted as first choice therapy in a variety of patients, especially those with minor symptoms. At present, it still remains unknown whether a strict rate control strategy is associated with an improved prognosis in terms of mortality and morbidity. Our hyopthesis is that lenient rate control is not inferior to strict rate control in patients with permanent atrial fibrillation with and without heart failure in terms of cardiovascular mortality and morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs.
Therefore, we will include 500 patients with permanent AF and randomize the patients to 1. lenient rate control (heart rate in rest < 110 bpm) or 2. strict rate control: heart rate in rest < 80 bpm and during minor exercise < 110 bpm. Follow up will be between 2 and 3 years.
At present 28 centers have included 212 patients.
Doel van het onderzoek
Lenient rate control is not inferior to strict rate control in patients with permanent atrial fibrillation with and without heart failure in terms of cardiovascular mortality and morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs.
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 30001
Isabelle C. Gelder, van
Groningen 9700 RB
The Netherlands
+31 (0)50 3611327
i.c.van.gelder@thorax.umcg.nl
Wetenschappelijk
P.O. Box 30001
Isabelle C. Gelder, van
Groningen 9700 RB
The Netherlands
+31 (0)50 3611327
i.c.van.gelder@thorax.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with persistent AF < 12 months;
2. Age < 80 years;
3. Resting heart rate > 80 beats per minute;
4. On oral anticoagulation.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL385 |
NTR-old | NTR425 |
Ander register | : N/A |
ISRCTN | ISRCTN36532482 |