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Curing Atrial Fibrillation in Heart Failure

Primary Purpose

Chronic Heart Failure, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
radiofrequency ablation
ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril
Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
Aldosterone Antagonists - spironolactone
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Atrial Fibrillation, Radiofrequency Ablation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glasgow Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

medical therapy

Radiofrequency ablation (RFA)

Arm Description

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

Isolation of the pulmonary veins using radiofrequency ablation

Outcomes

Primary Outcome Measures

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 Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %
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

Secondary Outcome Measures

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.
Plasma B-type Natriuretic Peptide (BNP) at Baseline
Plasma B-type Natriuretic Peptide (BNP) measured at basline
Plasma B-type Natriuretic Peptide (BNP) at 6 Months
Plasma B-type Natriuretic Peptide (BNP)

Full Information

First Posted
February 14, 2006
Last Updated
May 29, 2012
Sponsor
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT00292162
Brief Title
Curing Atrial Fibrillation in Heart Failure
Official Title
Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Greater Glasgow and Clyde

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Atrial Fibrillation
Keywords
Chronic Heart Failure, Atrial Fibrillation, Radiofrequency Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
medical therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Radiofrequency ablation (RFA)
Arm Type
Active Comparator
Arm Description
Isolation of the pulmonary veins using radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Other Intervention Name(s)
radiofrequency ablation (RFA), pulmonary vein isolation (PVI)
Intervention Description
isolation of the pulmonary veins with radiofrequency ablation (RFA)
Intervention Type
Drug
Intervention Name(s)
ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril
Intervention Description
Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.
Intervention Type
Drug
Intervention Name(s)
Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
Intervention Description
Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.
Intervention Type
Drug
Intervention Name(s)
Aldosterone Antagonists - spironolactone
Intervention Description
Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.
Primary Outcome Measure Information:
Title
Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%
Description
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.
Time Frame
baseline and 6 months
Title
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)
Description
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %
Time Frame
Baseline
Title
Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months
Description
Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Plasma B-type Natriuretic Peptide (BNP)
Description
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.
Time Frame
baseline and 6 months
Title
Plasma B-type Natriuretic Peptide (BNP) at Baseline
Description
Plasma B-type Natriuretic Peptide (BNP) measured at basline
Time Frame
Baseline
Title
Plasma B-type Natriuretic Peptide (BNP) at 6 Months
Description
Plasma B-type Natriuretic Peptide (BNP)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek T Connelly, MBChB
Organizational Affiliation
Glasgow Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G31 2ER
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21051458
Citation
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. doi: 10.1136/hrt.2010.207340. Epub 2010 Nov 4.
Results Reference
derived

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Curing Atrial Fibrillation in Heart Failure

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