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

February 14, 2006
May 29, 2012
January 2007
July 2009   (final data collection date for primary outcome measure)
  • 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
Left Ventricular Ejection Fraction by MRI
Complete list of historical versions of study NCT00292162 on ClinicalTrials.gov Archive Site
  • 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)
  • Right ventricular ejection fraction
  • Maintenance of sinus rhythm
  • Left and right atrial and ventricular dimensions, areas and volumes
  • Left ventricular diastolic function
  • NYHA class
  • Plasma BNP
  • Functional status: 6 minute walk
  • Quality of life: Minnesota Living with Heart Failure, SF-36 and Kansas City Cardiomyopathy questionnaires
Not Provided
Not Provided
 
Curing Atrial Fibrillation in Heart Failure
Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Heart Failure
  • Atrial Fibrillation
  • Procedure: radiofrequency ablation
    isolation of the pulmonary veins with radiofrequency ablation (RFA)
    Other Names:
    • radiofrequency ablation (RFA)
    • pulmonary vein isolation (PVI)
  • 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: 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
    Interventions:
    • Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril
    • Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
    • Drug: Aldosterone Antagonists - spironolactone
  • Active Comparator: Radiofrequency ablation (RFA)
    Isolation of the pulmonary veins using radiofrequency ablation
    Intervention: Procedure: radiofrequency ablation
MacDonald MR, Connelly DT, Hawkins NM, Steedman T, Payne J, Shaw M, Denvir M, Bhagra S, Small S, Martin W, McMurray JJ, Petrie MC. Radiofrequency ablation for persistent atrial fibrillation in patients with advanced heart failure and severe left ventricular systolic dysfunction: a randomised controlled trial. Heart. 2011 May;97(9):740-7. Epub 2010 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00292162
05/S0704/47
Not Provided
Michael MacDonald, NHS Greater Glasgow and Clyde
NHS Greater Glasgow and Clyde
Not Provided
Principal Investigator: Derek T Connelly, MBChB Glasgow Royal Infirmary
NHS Greater Glasgow and Clyde
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP