The role of pharmacological heart failure therapy in LV recovery following INDEX catheter ablation for atrial fibrillation [AF] induced cardiomyopathy - the INDEX-AF Study (ACTRN12625000464460)

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 receive anti-heart failure pharmacotherapy (control) versus monitoring without anti-heart failure pharmacotherapy (intervention). The primary outcome will be change in left ventricular ejection fraction from baseline.

Trial phase

Phase 3

Trial participation type

This trial is for clinical research of something other than a drug or device.

Principal investigator

A/Prof Sandeep (Sunny) Prabhu

Key inclusion data

Key inclusion criteria: New diagnosis of suspected atrial fibrillation (AF) induced cardiomyopathy. 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)).
Key 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 greater than 130ms, Very severe LVEF dysfunction (defined as less than 20% on CMR). Contraindication to catheter ablation. Any condition with expected survival < 2 years. 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.