Curing Atrial Fibrillation in Heart Failure
- Conditions
- Chronic Heart FailureAtrial Fibrillation
- Interventions
- Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinoprilProcedure: radiofrequency ablationDrug: 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
- 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
- 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
Group Intervention Description medical therapy ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril 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 medical therapy Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol 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 medical therapy Aldosterone Antagonists - spironolactone 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 Radiofrequency ablation (RFA) radiofrequency ablation Isolation of the pulmonary veins using radiofrequency ablation
- Primary Outcome Measures
Name Time Method 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 Months 6 months Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months
- Secondary Outcome Measures
Name Time Method 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 Baseline Baseline Plasma B-type Natriuretic Peptide (BNP) measured at basline
Plasma B-type Natriuretic Peptide (BNP) at 6 Months 6 months Plasma B-type Natriuretic Peptide (BNP)
Trial Locations
- Locations (1)
Glasgow Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom