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Curing Atrial Fibrillation in Heart Failure

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NHS Trust

Status

Completed

Conditions

Atrial Fibrillation
Chronic Heart Failure

Treatments

Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril
Procedure: radiofrequency ablation
Drug: Aldosterone Antagonists - spironolactone

Study type

Interventional

Funder types

Other

Identifiers

NCT00292162
05/S0704/47

Details and patient eligibility

About

Heart failure is a condition that occurs when the heart muscle weakens and no longer contracts normally. Half of these patients have an irregularity of heart rhythm called atrial fibrillation (AF). Patients with both heart failure and AF spend more time in hospital, and die earlier than those with heart failure alone. AF is difficult to treat with conventional methods in patients with heart failure. Radiofrequency ablation is a new technique used to cure AF. The investigators aim to establish if radiofrequency ablation for atrial fibrillation in patients with advanced heart failure can result in marked improvement in the function of the heart.

Enrollment

41 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Informed consent
  • Persistent atrial fibrillation (AF)
  • New York Heart Association (NYHA) II, III and IV chronic heart failure (CHF) despite optimal medical therapy for at least 3 months
  • left ventricular ejection fraction (LVEF) <35% - as measured by radionuclide ventriculography (RNVG)
  • Patients with CHF secondary to ischaemic and non-ischaemic aetiology

Exclusion criteria

  • QRS duration >150ms (or QRS 120-150 with evidence of mechanical cardiac dysynchrony)
  • Magnetic resonance imaging (MRI) - incompatible metallic (ferrous) prosthesis
  • Primary valvular disease as a cause of CHF
  • Reversible causes of CHF
  • Acute myocarditis
  • Patients aged 18 or less
  • Patients having undergone revascularisation procedures within 6 months
  • Paroxysmal AF
  • Pregnancy
  • Expected cardiac transplantation within 6 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 2 patient groups

medical therapy
Active Comparator group
Description:
Standard therapy for heart failure with angiotensin converting enzyme inhibitors(ACE) - (Ramipril, enalapril, lisinopril, captopril, perindopril), beta-blocker (BB) - (carvedilol, bisoprolol, metoprolol), Aldosterone antagonists (spironolactone) +/- diuretics and digoxin
Treatment:
Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril
Drug: Aldosterone Antagonists - spironolactone
Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
Radiofrequency ablation (RFA)
Active Comparator group
Description:
Isolation of the pulmonary veins using radiofrequency ablation
Treatment:
Procedure: radiofrequency ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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