Curing Atrial Fibrillation in Heart Failure

NCT ID: NCT00292162

Last Updated: 2012-06-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Heart Failure Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril

Intervention Type DRUG

Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.

Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol

Intervention Type DRUG

Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.

Aldosterone Antagonists - spironolactone

Intervention Type DRUG

Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.

Radiofrequency ablation (RFA)

Isolation of the pulmonary veins using radiofrequency ablation

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type PROCEDURE

isolation of the pulmonary veins with radiofrequency ablation (RFA)

Interventions

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radiofrequency ablation

isolation of the pulmonary veins with radiofrequency ablation (RFA)

Intervention Type PROCEDURE

ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril

Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.

Intervention Type DRUG

Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol

Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.

Intervention Type DRUG

Aldosterone Antagonists - spironolactone

Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.

Intervention Type DRUG

Other Intervention Names

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radiofrequency ablation (RFA) pulmonary vein isolation (PVI)

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Michael MacDonald

Cardiology ST6

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derek T Connelly, MBChB

Role: PRINCIPAL_INVESTIGATOR

Glasgow Royal Infirmary

Locations

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Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 21051458 (View on PubMed)

Other Identifiers

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05/S0704/47

Identifier Type: -

Identifier Source: org_study_id

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