Curing Atrial Fibrillation in Heart Failure

• Sponsor: NHS Greater Glasgow and Clyde (Other)
• Overall Status: Completed
• CT.gov ID: NCT00292162
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% [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.

2. Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) [Baseline]

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

3. Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months [6 months]

   Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months

Secondary Outcome Measures

1. Plasma B-type Natriuretic Peptide (BNP) [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.

2. Plasma B-type Natriuretic Peptide (BNP) at Baseline [Baseline]

   Plasma B-type Natriuretic Peptide (BNP) measured at basline

3. Plasma B-type Natriuretic Peptide (BNP) at 6 Months [6 months]

   Plasma B-type Natriuretic Peptide (BNP)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael MacDonald, Cardiology ST6, NHS Greater Glasgow and Clyde
• ClinicalTrials.gov Identifier: NCT00292162
• Other Study ID Numbers: 05/S0704/47
• First Posted: Feb 15, 2006
• Last Update Posted: Jun 1, 2012
• Last Verified: May 1, 2012

• Keywords provided by Michael MacDonald, Cardiology ST6, NHS Greater Glasgow and Clyde: Chronic Heart Failure; Atrial Fibrillation; Radiofrequency Ablation
• Additional relevant MeSH terms: Heart Failure; Atrial Fibrillation; Metoprolol; Carvedilol; Ramipril; Enalapril; Lisinopril; Perindopril; Bisoprolol; Captopril; Spironolactone; Adrenergic beta-Antagonists; Mineralocorticoid Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors

Study Results

Participant Flow

Arm/Group Title	Medical Therapy	Radiofrequency Ablation
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.	Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
Period Title: Overall Study
STARTED	19	22
COMPLETED	18	20
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Medical Therapy	Radiofrequency Ablation	Total
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.	Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.	Total of all reporting groups
Overall Participants	19	22	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (8)	62 (6.7)	63 (7)
Sex: Female, Male (Count of Participants)
Female	4 21.1%	5 22.7%	9 22%
Male	15 78.9%	17 77.3%	32 78%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study

Arm/Group Title	Medical Therapy	Radiofrequency Ablation
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.	Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
Measure Participants	19	19
Mean (Standard Deviation) [percentage of blood ejected in one beat]	2.8 (6.8)	4.5 (11.1)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate a blood test or dropped out of the study

Arm/Group Title	Medical Therapy	Radiofrequency Ablation
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.	Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
Measure Participants	18	20
Mean (Standard Deviation) [picograms per millilitre]	85 (648)	-196 (1469)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study

Arm/Group Title	Medical Therapy	Radiofrequency Ablation
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.	Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
Measure Participants	19	19
Mean (Standard Deviation) [percentage of blood ejected in one beat]	43 (10)	36 (12)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medical Therapy	Radiofrequency Ablation
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.	Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
Measure Participants	19	19
Mean (Standard Deviation) [percentage of blood ejected in one beat]	46 (7)	41 (11)

5. Secondary Outcome

Title	Plasma B-type Natriuretic Peptide (BNP) at Baseline
Description	Plasma B-type Natriuretic Peptide (BNP) measured at basline
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medical Therapy	Radiofrequency Ablation
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.	Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
Measure Participants	19	19
Mean (Standard Deviation) [picograms per millilitre]	1846 (1687)	2550 (2150)

6. Secondary Outcome

Title	Plasma B-type Natriuretic Peptide (BNP) at 6 Months
Description	Plasma B-type Natriuretic Peptide (BNP)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medical Therapy	Radiofrequency Ablation
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.	Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
Measure Participants	19	19
Mean (Standard Deviation) [picograms per millilitre]	1931 (1671)	2354 (2632)

Adverse Events

Arm/Group Title	Medical Therapy		Radiofrequency Ablation
Arm/Group Description	This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.		Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
All Cause Mortality
	Medical Therapy		Radiofrequency Ablation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Medical Therapy		Radiofrequency Ablation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		4/22 (18.2%)
Cardiac disorders
Cardiac tamponade	0/19 (0%)	0	2/22 (9.1%)	2
heart failure hospitalisation	0/19 (0%)	0	1/22 (4.5%)	1
Nervous system disorders
Stroke	0/19 (0%)	0	1/22 (4.5%)	1
Other (Not Including Serious) Adverse Events
	Medical Therapy		Radiofrequency Ablation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.