CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 1,548
- Locations
- 2
- Primary Endpoint
- The primary outcome is defined as a composite of cardiovascular death, stroke and total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome.
Study Overview
Brief Summary
The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).
Detailed Description
HFpEF accounts for approximately half of HF diagnoses and HFmrEF adds another 20%. HFpEF patients are predisposed to AF with a prevalence of AF up to 65%. Conversely, the presence of AF increases the likelihood of subsequent HFpEF by up to 4-fold across diverse populations. The vulnerable hemodynamic state in HFpEF patients due to LV diastolic dysfunction can be significantly affected by AF with loss of atrial contraction and reduction in cardiac output. Thus, presence of AF in HFpEF patients leads to a significant increase in hospitalization, mortality and stroke.
Restoring and maintaining sinus rhythm in patients with HFpEF and AF could reduce cardiovascular (CV) outcomes. Catheter ablation (CA), particularly when performed as initial rhythm control, results in less recurrences of AF than anti arrhythmic drug therapy. In patients with HF with reduced ejection fraction (HFrEF) and AF, CA showed a significant reduction in all-cause mortality and worsening HF admissions compared to medical therapy.
No randomized clinical trial has tested or is currently testing the effects of CA on CV outcomes in patients with HFmrEF or HFpEF and AF. To address this, CABA-HFPEF tests whether CA can improve CV outcomes compared to usual care in these patients. The results of CABA-HFPEF will critically extend the current evidence on ablation-based rhythm control to this large population in dire need for treatments that improve clinical outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The primary outcome is defined as a composite of cardiovascular death, stroke and total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome.
Time Frame: Estimated first patient in to last patient out 48 months.
Secondary Outcomes
- Unplanned hospitalization for atrial arrhythmia(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Total (first and recurrent) planned and unplanned cardiovascular hospitalizations(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Cardiovascular death(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Nights spent in hospital(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Change in EHRA score at 12 months FU(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Change in quality of life at 12 months FU(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- All-cause mortality(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Stroke(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Atrial fibrillation burden (percentage of AF at 12 months FU Holter ECG)(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Change in NYHA class at 12 months FU(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Days alive and out of hospital(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
- Change in left ventricular ejection fraction at 12 months FU(The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months)
Investigators
Abdul Parwani
Head of Electrophysiology
Charite University, Berlin, Germany