None listed
Conditions
Brief summary
We propose a randomised control clinical trial to explore whether patients with AF-induced cardiomyopathy undergoing catheter ablation can avoid anti-heart failure pharmacotherapy. Patients will be randomised to recieve anti-heart failure pharmacotherapy (control) versus monitoring without anti-heart failure pharmacotherapy (intervention). The primary outcome will be difference in left ventricular ejection fraction at 6 months.
Interventions
This is a randomised control trial for to explore whether patients with atrial fibrillation (AF) induced cardiomyopathy undergoing AF catheter ablation can avoid heart failure (HF) pharmacotherapy.
All patients will undergo early AF catheter ablation within 1 month of enrolment (left ventricular ejection fraction is less than or equal to 40% and there is absence of late gadolinium enhancement).
The intervention arm will be monitored following catheter ablation without the addition of anti HF
This is a randomised control trial for to explore whether patients with atrial fibrillation (AF) induced cardiomyopathy undergoing AF catheter ablation can avoid heart failure (HF) pharmacotherapy. All patients will undergo early AF catheter ablation within 1 month of enrolment (left ventricular ejection fraction is less than or equal to 40% and there is absence of late gadolinium enhancement). The intervention arm will be monitored following catheter ablation without the addition of anti HF pharmacotherapy through follow-up in hospital at 6 weeks, 3 months and 6 months post randomisation. Adherence to the intervention will be via participant self report.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria Age>18 years New diagnosis of suspected atrial fibrillation (AF) induced cardiomyopathy - Left ventricular ejection fraction (LVEF) less than or equal to 40% within 3 months of AF diagnosis to allow for delays in EF evaluation - Minimal/Absence of late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) (defined burden <5%) - Elevated B-type natriuretic peptide (BNP) or N-terminal (NT)-proBNP Able to consent Willing to adhere to follow up requirements Recovering LVEF 1 month after catheter ablation (defined as LVEF greater than or equal to 50% or LVEF improved greater than or equal to 10% from initial transthoracic echocardiogram (TTE))
Exclusion criteria
Patients with known contributing cause of LV dysfunction - Ischaemic cardiomyopathy - Valvular heart disease - Hypertrophic cardiomyopathy - Uncontrolled alcohol intake - Other cause of cardiomyopathy (e.g. thyroid disease) - LBBB or QRSD>130ms Very severe LVEF dysfunction (defined as <20% on CMR) Contraindication to catheter ablation Any condition with expected survival < 2 years Unable to provide informed consent Patients with a clear indication for elements of heart failure therapy for reasons other than heart failure where alternative agents are contra-indicated or inappropriate
Outcome results
None listed