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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medical therapy | Active Comparator | 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 |
|
| Radiofrequency ablation (RFA) | Active Comparator | Isolation of the pulmonary veins using radiofrequency ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency ablation | Procedure | isolation of the pulmonary veins with radiofrequency ablation (RFA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 6 months |
| Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) | Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in % | Baseline |
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek T Connelly, MBChB | Glasgow Royal Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgow Royal Infirmary | Glasgow | Scotland | G31 2ER | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21051458 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril | Drug | Evidence based treatment for heart failure. Dose and type will depend on patient tolerability. |
|
| Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol | Drug | Evidence based treatment for heart failure. Dose and type will depend on patient tolerance. |
|
| Aldosterone Antagonists - spironolactone | Drug | Evidence based treatment for heart failure. Dose and type will depend on patient to treatment. |
|
| Plasma B-type Natriuretic Peptide (BNP) at Baseline | Plasma B-type Natriuretic Peptide (BNP) measured at basline | Baseline |
| Plasma B-type Natriuretic Peptide (BNP) at 6 Months | Plasma B-type Natriuretic Peptide (BNP) | 6 months |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | percentage of blood ejected in one beat | baseline and 6 months |
|
|
| ||||||||||||||||||||||||||||
| 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. | 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 | Posted | Mean | Standard Deviation | picograms per millilitre | baseline and 6 months |
| ||||||||||||||||||||||||||||||
| Primary | Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) | Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in % | 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 | Posted | Mean | Standard Deviation | percentage of blood ejected in one beat | Baseline |
|
| |||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | percentage of blood ejected in one beat | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Plasma B-type Natriuretic Peptide (BNP) at Baseline | Plasma B-type Natriuretic Peptide (BNP) measured at basline | Posted | Mean | Standard Deviation | picograms per millilitre | Baseline |
|
| ||||||||||||||||||||||||||||||
| Secondary | Plasma B-type Natriuretic Peptide (BNP) at 6 Months | Plasma B-type Natriuretic Peptide (BNP) | Posted | Mean | Standard Deviation | picograms per millilitre | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 19 | 0 | 19 | ||
| EG001 | 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. | 4 | 22 | 0 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Cardiac tamponade | Cardiac disorders | Non-systematic Assessment |
| ||
| heart failure hospitalisation | Cardiac disorders | within 1 week of the procedure |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael MacDonald | NHS | 01412112000 | michael.macdonald@nhs.net |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D004656 | Enalapril |
| D002216 | Captopril |
| D020913 | Perindopril |
| D017706 | Lisinopril |
| D000319 | Adrenergic beta-Antagonists |
| D008790 | Metoprolol |
| D017298 | Bisoprolol |
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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