Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

Официальное название

A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and Preserved Ejection Fraction (CABANA-RAFT HF): A Pilot Study

Обзор

This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.

Вмешательства

• Процедура Catheter Ablation for Atrial Fibrillation
  Participants randomized to this arm will undergo catheter ablation within 4 weeks of randomization. Pulmonary vein isolation is required; additional ablation strategies may be applied at investigator discretion. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.
• Препарат Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)
  Participants randomized to this arm will receive pharmacologic therapy to achieve guideline-recommended heart rate control (resting HR \<80 bpm, \<110 bpm with exercise). Therapy may include beta-blockers, non-dihydropyridine calcium channel blockers, or digoxin. If adequate control is not achieved with medication, AV nodal ablation and pacing may be used. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.

Первичные конечные точки

• Feasibility of Trial Conduct [Срок оценки: 12 months after randomization]

Вторичные конечные точки (11)

• Composite of Cardiovascular Mortality and Heart Failure Hospitalization [Срок оценки: Up to 12 months post-randomization]
• All-Cause Mortality [Срок оценки: Up to 12 months]
• Cardiovascular Hospitalizations and ED Visits (Non-HF) [Срок оценки: Up to 12 months]
• Quality of Life: EQ-5D (Euroquol 5D Questionnaire) [Срок оценки: Baseline, 12 months]
• Quality of Life: AFEQT (Atrial Fibrillation Effect on Quality of Life) Questionnaire [Срок оценки: Baseline, 12 months]
• Quality of life- KCCQ-12 (Kansas City Cardiomyopathy Questionnaire-12) [Срок оценки: Baseline, 12 months]
• Atrial Fibrillation Burden [Срок оценки: Baseline, 3, 6, and 12 months]
• Change in NT-proBNP levels [Срок оценки: Baseline, 12 months]
• Change in Left Ventricular Ejection Fraction (LVEF) [Срок оценки: Baseline, 12 months]
• Exercise Capacity (6-Minute Walk Distance) [Срок оценки: Baseline, 12 months]
• Recruitment Metrics [Срок оценки: Throughout 12-month recruitment]

Критерии участия

Критерии включения

• Age ≥18 years
• Diagnosis of atrial fibrillation (documented on Holter, rhythm strip, or ECG)
• New York Heart Association (NYHA) class II-III heart failure
• Left ventricular ejection fraction (LVEF) >40%
• Meet specific NT-proBNP criteria:
• If HF hospitalization within 6 months prior to screening: NT-proBNP >200 pg/ml (if not in AF at screening) or >600 pg/ml (if in AF at screening)
• Otherwise: NT-proBNP >300 pg/ml (if not in AF at screening) or >900 pg/ml (if in AF at screening)
• On stable guideline-directed medical therapy for ≥1 month
• On stable diuretic dose for ≥2 weeks
• Suitable for either ablation-based rhythm control or rate control strategy

Критерии исключения

• Permanent atrial fibrillation diagnosis
• Prior catheter ablation for atrial fibrillation
• NYHA class IV heart failure
• Rheumatic heart disease
• Moderate or severe mitral stenosis
• Mechanical mitral valve
• Severe aortic stenosis or severe aortic/mitral regurgitation
• Renal failure requiring dialysis
• Contraindication to oral anticoagulation
• Infiltrative cardiomyopathies
• Complex congenital heart disease
• Untreated thyroid disease
• Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
• Participation in another clinical trial
• Inability to provide informed consent
• Other serious non-cardiovascular condition with life expectancy ≤1 year
• Age <18 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• QEII HSC — Halifax

Идентификаторы

NCT: NCT07272902 · CABANA-RAFT HF · 1032000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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