Curing Atrial Fibrillation in Heart Failure

May 29, 2012 updated by: Michael MacDonald, NHS Greater Glasgow and Clyde

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • Glasgow Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 months
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)
Time Frame: Baseline
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %
Baseline
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 months
Plasma B-type Natriuretic Peptide (BNP) at Baseline
Time Frame: Baseline
Plasma B-type Natriuretic Peptide (BNP) measured at basline
Baseline
Plasma B-type Natriuretic Peptide (BNP) at 6 Months
Time Frame: 6 months
Plasma B-type Natriuretic Peptide (BNP)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Derek T Connelly, MBChB, Glasgow Royal Infirmary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 29, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/S0704/47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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