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- Ensayo clínico NCT01411371
Catheter Ablation Versus Medical Treatment of AF in Heart Failure (CAMTAF)
Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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UK
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London, UK, Reino Unido, EC1A 7BE
- Barts & The London NHS Trust
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Persistent atrial fibrillation
- Symptomatic heart failure
Exclusion Criteria:
- Reversible causes of heart failure
- Contraindications to catheter ablation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Catheter Ablation
Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm. |
Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010). |
|
Comparador activo: Medical treatment alone
Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated). |
Medical treatment of persistent AF as 'normal care'. Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference in Ejection Fraction Between Groups
Periodo de tiempo: 6 months
|
Difference in left ventricular ejection fraction between groups on echocardiography at 6 months |
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference in Peak VO2 Between Groups
Periodo de tiempo: 6 months
|
Looking at peak volume oxygen updake between groups |
6 months
|
|
Difference in NYHA Class Between Groups
Periodo de tiempo: 6 months
|
NYHA Functional Classification. classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain (Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. No NYHA class listed or unable to determine.) |
6 months
|
|
Difference in BNP Between Groups
Periodo de tiempo: 6 months
|
Difference in BNP between groups from 1 month onwards |
6 months
|
|
Difference in Quality of Life Between Groups
Periodo de tiempo: 6 months
|
Assessed from 1 month onwards. Using SF36 (total score indicating a range of low to high Quality of life) and Minnessota questionaire (Minnesota Living With Heart Failure Questionnaire (MLHFQ) uses a scale from 0 to 105, where higher scores indicate poorer health-related quality of life) |
6 months
|
|
Reduction in End Systolic Volume
Periodo de tiempo: 6 months compared to baseline
|
Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline. |
6 months compared to baseline
|
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Difference in Heart Failure Symptoms
Periodo de tiempo: 6 months
|
Comparison between groups in heart failure symptoms using The Minnesota Living with Heart Failure Questionnaire (health related quality of life- 0 to 105. Lower scores mean a better quality of life; higher scores mean worse limitations) |
6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Richard J Schilling, MD FRCP, Professor of Cardiology, Barts & The London NHS Trust
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 05/Q0605/47
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