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Curing Atrial Fibrillation in Heart Failure

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ClinicalTrials.gov Identifier: NCT00292162
Recruitment Status : Completed
First Posted : February 15, 2006
Results First Posted : June 1, 2012
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
Michael MacDonald, NHS Greater Glasgow and Clyde

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Atrial Fibrillation Procedure: radiofrequency ablation Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol Drug: Aldosterone Antagonists - spironolactone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure
Study Start Date : January 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: medical therapy
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
Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.

Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.

Drug: Aldosterone Antagonists - spironolactone
Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.
Active Comparator: Radiofrequency ablation (RFA)
Isolation of the pulmonary veins using radiofrequency ablation
 Procedure: radiofrequency ablation
isolation of the pulmonary veins with radiofrequency ablation (RFA)
Other Names:
  • radiofrequency ablation (RFA)
  • pulmonary vein isolation (PVI)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% [ Time Frame: 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.

  2. Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline ]
    Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %

  3. Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months [ Time Frame: 6 months ]
    Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months


Secondary Outcome Measures :
  1. Plasma B-type Natriuretic Peptide (BNP) [ Time Frame: 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.

  2. Plasma B-type Natriuretic Peptide (BNP) at Baseline [ Time Frame: Baseline ]
    Plasma B-type Natriuretic Peptide (BNP) measured at basline

  3. Plasma B-type Natriuretic Peptide (BNP) at 6 Months [ Time Frame: 6 months ]
    Plasma B-type Natriuretic Peptide (BNP)


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292162


Locations
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United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
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Principal Investigator: Derek T Connelly, MBChB Glasgow Royal Infirmary
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael MacDonald, Cardiology ST6, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT00292162    
Other Study ID Numbers: 05/S0704/47
First Posted: February 15, 2006    Key Record Dates
Results First Posted: June 1, 2012
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Michael MacDonald, NHS Greater Glasgow and Clyde:
Chronic Heart Failure
Atrial Fibrillation
Radiofrequency Ablation
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Metoprolol
Carvedilol
Ramipril
Enalapril
Lisinopril
Bisoprolol
Perindopril
Captopril
Spironolactone
 Adrenergic beta-Antagonists
Mineralocorticoid Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists