Atrial Fibrillation, Chronic Heart Failure
Conditions
Keywords
Chronic Heart Failure, Atrial Fibrillation, Radiofrequency Ablation
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.
Interventions
PROCEDUREradiofrequency ablation
isolation of the pulmonary veins with radiofrequency ablation (RFA)
DRUGACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril
Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.
Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.
DRUGAldosterone Antagonists - spironolactone
Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.
Sponsors
NHS Greater Glasgow and Clyde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) | Baseline | Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in % |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Plasma B-type Natriuretic Peptide (BNP) at Baseline | Baseline | Plasma B-type Natriuretic Peptide (BNP) measured at basline |
| Plasma B-type Natriuretic Peptide (BNP) at 6 Months | 6 months | Plasma B-type Natriuretic Peptide (BNP) |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medical Therapy 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. | 19 |
| Radiofrequency Ablation 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. | 22 |
| Total | 41 |
Baseline characteristics
| Characteristic | Medical Therapy | Radiofrequency Ablation | Total |
|---|---|---|---|
| Age Continuous | 64 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 6.7 | 63 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 22 |
| serious Total, serious adverse events | 0 / 19 | 4 / 22 |
Outcome results
Primary
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %
Time frame: Baseline
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) | 43 percentage of blood ejected in one beat | Standard Deviation 10 |
| Radiofrequency Ablation | Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) | 36 percentage of blood ejected in one beat | Standard Deviation 12 |
Primary
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.
Time frame: baseline and 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% | 2.8 percentage of blood ejected in one beat | Standard Deviation 6.8 |
| Radiofrequency Ablation | Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% | 4.5 percentage of blood ejected in one beat | Standard Deviation 11.1 |
Primary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months | 46 percentage of blood ejected in one beat | Standard Deviation 7 |
| Radiofrequency Ablation | Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months | 41 percentage of blood ejected in one beat | Standard Deviation 11 |
Secondary
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.
Time frame: baseline and 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Plasma B-type Natriuretic Peptide (BNP) | 85 picograms per millilitre | Standard Deviation 648 |
| Radiofrequency Ablation | Plasma B-type Natriuretic Peptide (BNP) | -196 picograms per millilitre | Standard Deviation 1469 |
Secondary
Plasma B-type Natriuretic Peptide (BNP) at 6 Months
Plasma B-type Natriuretic Peptide (BNP)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Plasma B-type Natriuretic Peptide (BNP) at 6 Months | 1931 picograms per millilitre | Standard Deviation 1671 |
| Radiofrequency Ablation | Plasma B-type Natriuretic Peptide (BNP) at 6 Months | 2354 picograms per millilitre | Standard Deviation 2632 |
Secondary
Plasma B-type Natriuretic Peptide (BNP) at Baseline
Plasma B-type Natriuretic Peptide (BNP) measured at basline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Plasma B-type Natriuretic Peptide (BNP) at Baseline | 1846 picograms per millilitre | Standard Deviation 1687 |
| Radiofrequency Ablation | Plasma B-type Natriuretic Peptide (BNP) at Baseline | 2550 picograms per millilitre | Standard Deviation 2150 |