WITHDRAWal of heart failure directed therapies in recovered Atrial Fibrillation mediated cardiomyopathy- the WITHDRAW-AF study

Not Applicable

Completed

• Conditions: atrial fibrillation; heart failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621000896875
• Lead Sponsor: Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-08
• Study Completion: 2024-06-03
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age>18 years
- AF mediated cardiomyopathy
Previous LVEF <40% in the setting of AF with recovery to >50% within 6 months after
restoration of sinus rhythm (with anti-arrhythmic medications, electrical cardioversion,
catheter ablation or any combination of these)
- NYHA class I
- Currently on pharmacological anti-heart failure therapy including at least 2 of:
-ACE inhibitor or Angiotensin receptor antagonist
-Diuretic (excluding MRA)
-Cardiac specific beta blocker
-Mineralocorticoid receptor antagonist
-Entresto (Sacubitril/Valsartan)
- No recurrence of AF with previous 6 months
- No heart failure related admissions with last 6 months
- Cardiac MRI demonstrating
-LVEF >/=50%
-The absence of ventricular late gadolinium enhancement
-Indexed LVEDV less than 10% upper limit of normal
- Able to consent
- Willing to adhere to follow up requirements

Exclusion Criteria

- Patients with unsuccessful rhythm control
- Patients with known contributing cause of LV dysfunction including
-Ischaemic cardiomyopathy
-Valvular heart disease
-Hypertrophic cardiomyopathy
-Uncontrolled current/ongoing alcohol intake
-Other cause of cardiomyopathy (eg thyroid disease)
- Significant renal impairment (eGFR<30mL/min/1.73m2)
- Contraindication to
-cardiac MRI,
-catheter ablation or
-anti-coagulation
- Any condition with expected survival < 2 years
- Patients with a clear indication for ACE/ARB therapy for reasons other than heart failure where alternative agents are contra-indicated or inappropriate
- Unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Should read as: The primary endpoint is comparison of phased withdrawal versus continued medical therapy, defined as maintenance of LVEF >/=50% on CMR at 6 and 12 months. This allows for inter-observer variability between imaging up to +/-5% as recognised previously. as per prior published literature and recommended by cardiac imaging specialists involved in thee trial design. [ 6 and 12 months post randomisation]