Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure - The DanAblate-HF Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,616
- 试验地点
- 12
- 主要终点
- Time to hospitalization for worsening HF or cardiovascular death
研究概览
简要总结
The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment.
详细描述
Atrial fibrillation (AF) is the most common arrhythmia in patients with heart failure (HF), with rates ranging between 20-65%, depending on age, severity of HF, subtypes of HF and duration of HF. The two conditions have an intricate and often overlapping pathophysiology, with each condition leading to development of the other, as well as progression of disease. Studies have shown that the presence of AF in HF patients is associated with increased morbidity and mortality, deterioration in HF, exacerbated HF symptoms, and reduced quality of life. The optimal treatment of AF in the presence of HF remains unknown. Currently, there is a pull towards catheter ablation as first-line therapy for AF in HF patients. However, there is no solid scientific evidence to support this approach. Furthermore, it is unknown whether early rhythm control by catheter ablation in HF patients is beneficial.
The investigators aim to conduct a pragmatic, randomized clinical trial designed to evaluate the efficacy and safety of early catheter ablation for AF in patients with HF compared with standard treatment.
Eligible patients with HF and AF will be prospectively screened from all Danish hospitals and randomized 1:1 to early catheter ablation with pulmonary vein isolation (within 6 weeks) or standard guideline directed treatment for AF. Patients with reversible causes for AF, conditions that preclude the use of catheter ablation or previous catheter ablation for AF will be excluded from the study. Randomization and follow-up will be conducted at six specialized sites in Denmark. There will be one scheduled on-site 12-months follow-up visit after randomization. All clinical follow-up will be conducted at the patient's local hospital, according to standard practice and out of trial setting. Information regarding hospital visits/admissions, events, adverse events, changes in medication, cross-over, heart rhythm and rate, and results of relevant blood-work will be ascertained through systematic patient chart-review at pre-specified time-points. The results from this trial will mold future treatment of AF in HF patients. The investigators hypothesize that early catheter ablation reduces the risk of HF hospitalizations and mortality when compared with standard treatment, thereby significantly improving the clinical prognosis for patients with HF and AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HF patients with AF within the past 12 months
- •HF is defined as all of the below (all must apply)
- •Clinically assessed Heart Failure with Reduced Ejection Fraction (HFrEF)
- •An indication for initiation or ongoing guideline directed medical therapy for HFrEF, according to current Heart Failure guidelines
- •LVEF < 50% at any point during the past 12 months
- •AF is defined as one or more of the following:
- •A. Symptomatic AF, documented by ECG, Holter of CIED
- •B. Asymptomatic AF with one or more of the following:
- •Clinical indication for rhythm or rate control (documented by ECG, telemetry, Holter, CIED)
- •≥2 ECG detected AF episodes within 3 months (on separate dates)
- •Holter detected AF with a continuous duration of more than 6 hours
- •CIED detected AF with continuous duration >24 hours
- •18 years ≤ Age <80 years
- •Optimal medical therapy for HFrEF or planned/current uptitration in guideline directed medical therapy for HFrEF
- •Treatment with anticoagulation for stroke prevention, initiated according to guidelines for treatment of AF
排除标准
- •Life-expectancy < 1 year
- •Contraindications or unacceptable side effects to rate limiting drugs AND amiodarone
- •LA size (indexed for BSA) > 60 ml/m2 (volume) on echo within the last year
- •Documented persistent/permanent AF > 1 year
- •Previous AF ablation/surgery
- •Reversible causes of AF (including, but not limited to, infection within 14 days, untreated thyroid disease, surgery)
- •Severe valvular disease
- •Acute myocardial infarction, cardiothoracic surgery or stroke within the past 3 months
- •Planned cardiothoracic surgery
- •Listed for heart transplant
- •Contraindications for anticoagulation therapy or catheter ablation
- •Severe kidney disease (CKD≥5)
- •Patient unwilling to try medical therapy for AF
- •Patient unwilling/unable to give informed consent for study participation
结局指标
主要结局
Time to hospitalization for worsening HF or cardiovascular death
时间窗: From baseline to study completion, with a minimum of 1 year
The primary outcome of the trial is defined as the time from randomization to the composite of one the following, whichever comes first * Hospitalization for worsening HF * Cardiovascular (CV) mortality Hospitalization for worsening HF will be defined as hospital admission primarily for HF (as deemed so by the event adjudication committee) with a duration of at least 24 hours and requiring intensification of diuretic treatment. CV mortality will be defined as all deaths resulting from one or more of the following: HF, stroke, acute myocardial infarction, CV procedural deaths, CV hemorrhage, arrythmia, sudden cardiac death, death due to other CV causes and death of undetermined cause.
次要结局
- Time to primary outcome stratified by symptomatic and asymptomatic AF(From baseline to study completion, with a minimum of 1 year)
- Time to primary outcome stratified by paroxysmal or persistent AF(From baseline to study completion, with a minimum of 1 year)
- Change in self-assessed health(From baseline to 12 months)
- Change in New York Heart Association (NYHA) class(From baseline to 12 months)
- Time to first-time AF hospitalization(From baseline to study completion, with a minimum of 1 year)
- Time to primary outcome stratified by age(From baseline to study completion, with a minimum of 1 year)
- Time to primary outcome stratified by left ventricular ejection fraction (LVEF)(From baseline to study completion, with a minimum of 1 year)
- Change in Quality of Life(From baseline to 12 months)
- Change in European Heart Rhythm Association score of atrial fibrillation (EHRA class)(From baseline to 12 months)
- Time to cardiovascular death(From baseline to study completion, with a minimum of 1 year)
- Time to all-cause mortality(From baseline to study completion, with a minimum of 1 year)
- Time to first heart failure hospitalization(From baseline to study completion, with a minimum of 1 year)
- Time to primary outcome stratified by sex(From baseline to study completion, with a minimum of 1 year)
研究者
Sam Riahi
Professor
Aalborg University Hospital