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Curing Atrial Fibrillation in Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael MacDonald, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00292162
First received: February 14, 2006
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %

  • Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months


Secondary Outcome Measures:
  • Plasma B-type Natriuretic Peptide (BNP) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Plasma B-type Natriuretic Peptide (BNP) measured at basline

  • Plasma B-type Natriuretic Peptide (BNP) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Plasma B-type Natriuretic Peptide (BNP)


Enrollment: 41
Study Start Date: January 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292162

Locations
United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: Derek T Connelly, MBChB Glasgow Royal Infirmary
  More Information

No publications provided by NHS Greater Glasgow and Clyde

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael MacDonald, Cardiology ST6, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT00292162     History of Changes
Other Study ID Numbers: 05/S0704/47
Study First Received: February 14, 2006
Results First Received: August 1, 2011
Last Updated: May 29, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
Chronic Heart Failure
Atrial Fibrillation
Radiofrequency Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Metoprolol
Metoprolol succinate
Bisoprolol
Carvedilol
Aldosterone Antagonists
Spironolactone
Angiotensin-Converting Enzyme Inhibitors
Captopril
 Enalapril
Enalaprilat
Lisinopril
Ramipril
Perindopril
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013