Curing Atrial Fibrillation in Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure

Conditions
-----------------
Chronic Heart Failure, Atrial Fibrillation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: medical therapy<br>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 | Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril<br>* Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.<br>Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol<br>* Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.<br>Drug: Aldosterone Antagonists - spironolactone<br>* Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.<br>|
| Active Comparator: Radiofrequency ablation (RFA)<br>Isolation of the pulmonary veins using radiofrequency ablation | Procedure: radiofrequency ablation<br>* isolation of the pulmonary veins with radiofrequency ablation (RFA)<br>* Other names: pulmonary vein isolation (PVI);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% | 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. | baseline and 6 months | 
| Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) | Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in % | Baseline | 
| Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months | Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma B-type Natriuretic Peptide (BNP) | 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. | baseline and 6 months | 
| Plasma B-type Natriuretic Peptide (BNP) at Baseline | Plasma B-type Natriuretic Peptide (BNP) measured at basline | Baseline | 
| Plasma B-type Natriuretic Peptide (BNP) at 6 Months | Plasma B-type Natriuretic Peptide (BNP) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Heart Failure, Atrial Fibrillation, Radiofrequency Ablation