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Curing Atrial Fibrillation in Heart Failure

Not Applicable
Completed
Conditions
Chronic Heart Failure
Atrial Fibrillation
Interventions
Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril
Procedure: radiofrequency ablation
Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
Registration Number
NCT00292162
Lead Sponsor
NHS Greater Glasgow and Clyde
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
medical therapyACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinoprilStandard 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
medical therapyBeta Blocker (BB) - metoprolol, bisoprolol, carvedilolStandard 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
medical therapyAldosterone Antagonists - spironolactoneStandard 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
Radiofrequency ablation (RFA)radiofrequency ablationIsolation of the pulmonary veins using radiofrequency ablation
Primary Outcome Measures
NameTimeMethod
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)Baseline

Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %

Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%baseline and 6 months

left ventricular ejection fraction (LVEF) is a measure of the % of blood ejected from the ventricle in one heart beat. It is a measure of cardiac function. We measured LVEF at baseline and at 6 months, to assess whether there had been a change in the patients cardiac function over time.

Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months6 months

Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months

Secondary Outcome Measures
NameTimeMethod
Plasma B-type Natriuretic Peptide (BNP)baseline and 6 months

venous blood taken to assess levels of the above peptide. High evels of the peptide are associated with adverse prognosis. Blood levels are taken at baseline and 6 months. The change over 6 months is assessed, thereore it is possible to have a negative number if the level falls.

Plasma B-type Natriuretic Peptide (BNP) at BaselineBaseline

Plasma B-type Natriuretic Peptide (BNP) measured at basline

Plasma B-type Natriuretic Peptide (BNP) at 6 Months6 months

Plasma B-type Natriuretic Peptide (BNP)

Trial Locations

Locations (1)

Glasgow Royal Infirmary

🇬🇧

Glasgow, Scotland, United Kingdom

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