Trial Outcomes & Findings for Curing Atrial Fibrillation in Heart Failure (NCT NCT00292162)
NCT ID: NCT00292162
Last Updated: 2012-06-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2012-06-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
22
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Curing Atrial Fibrillation in Heart Failure
Baseline characteristics by cohort
| Measure |
Medical Therapy
n=19 Participants
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.
|
Radiofrequency Ablation
n=22 Participants
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
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64 years
STANDARD_DEVIATION 8 • n=99 Participants
|
62 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
63 years
STANDARD_DEVIATION 7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
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.
|
Radiofrequency Ablation
n=19 Participants
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.
|
|---|---|---|
|
Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%
|
2.8 percentage of blood ejected in one beat
Standard Deviation 6.8
|
4.5 percentage of blood ejected in one beat
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
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.
|
Radiofrequency Ablation
n=19 Participants
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.
|
|---|---|---|
|
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)
|
43 percentage of blood ejected in one beat
Standard Deviation 10 • Interval 33.0 to 53.0
|
36 percentage of blood ejected in one beat
Standard Deviation 12 • Interval 24.0 to 48.0
|
PRIMARY outcome
Timeframe: 6 monthsLeft Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
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.
|
Radiofrequency Ablation
n=19 Participants
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.
|
|---|---|---|
|
Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months
|
46 percentage of blood ejected in one beat
Standard Deviation 7 • Interval 39.0 to 53.0
|
41 percentage of blood ejected in one beat
Standard Deviation 11 • Interval 30.0 to 52.0
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Medical Therapy
n=18 Participants
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.
|
Radiofrequency Ablation
n=20 Participants
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.
|
|---|---|---|
|
Plasma B-type Natriuretic Peptide (BNP)
|
85 picograms per millilitre
Standard Deviation 648 • Interval -563.0 to 733.0
|
-196 picograms per millilitre
Standard Deviation 1469 • Interval -1665.0 to 1273.0
|
SECONDARY outcome
Timeframe: BaselinePlasma B-type Natriuretic Peptide (BNP) measured at basline
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
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.
|
Radiofrequency Ablation
n=19 Participants
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.
|
|---|---|---|
|
Plasma B-type Natriuretic Peptide (BNP) at Baseline
|
1846 picograms per millilitre
Standard Deviation 1687 • Interval 159.0 to 3533.0
|
2550 picograms per millilitre
Standard Deviation 2150 • Interval 400.0 to 4700.0
|
SECONDARY outcome
Timeframe: 6 monthsPlasma B-type Natriuretic Peptide (BNP)
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
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.
|
Radiofrequency Ablation
n=19 Participants
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.
|
|---|---|---|
|
Plasma B-type Natriuretic Peptide (BNP) at 6 Months
|
1931 picograms per millilitre
Standard Deviation 1671 • Interval 260.0 to 3608.0
|
2354 picograms per millilitre
Standard Deviation 2632 • Interval -278.0 to 4986.0
|
Adverse Events
Medical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Radiofrequency Ablation
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medical Therapy
n=19 participants at risk
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.
|
Radiofrequency Ablation
n=22 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/19
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/19
|
9.1%
2/22 • Number of events 2
|
|
Cardiac disorders
heart failure hospitalisation
|
0.00%
0/19
|
4.5%
1/22 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place