Chronic Heart FailureNCT00292162

Curing Atrial Fibrillation in Heart Failure

A study testing radiofrequency ablation, ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril and Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol in people with Chronic Heart Failure and Atrial Fibrillation, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Chronic Heart Failure, Atrial Fibrillation
What is being tested?: radiofrequency ablation, ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril and Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited Kingdom
Study dates: Jan 2007to Jul 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

Patients having undergone revascularisation procedures within 6 months
Paroxysmal AF
Pregnancy
Expected cardiac transplantation within 6 months

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER

Other trials in United Kingdom

About this study

Official title: 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.

Conditions: Chronic Heart Failure, Atrial Fibrillation
Being tested: radiofrequency ablation, ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril, Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol, Aldosterone Antagonists - spironolactone
Keywords: Chronic Heart Failure, Atrial Fibrillation, Radiofrequency Ablation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

radiofrequency ablationProcedure or surgery
Also called radiofrequency ablation (RFA), pulmonary vein isolation (PVI)
isolation of the pulmonary veins with radiofrequency ablation (RFA)
ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinoprilDrug
Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.
Beta Blocker (BB) - metoprolol, bisoprolol, carvedilolDrug
Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.
Aldosterone Antagonists - spironolactoneDrug
Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.

Study groups in NCT00292162
Study group	Role	What they receive
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 Receives: Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril; Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol; Drug: Aldosterone Antagonists - spironolactone
Radiofrequency ablation (RFA)	Active comparator	Isolation of the pulmonary veins using radiofrequency ablation Receives: Procedure: radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 %
Measured: 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
Measured: 6 months

Secondary outcomes (3)

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.
Measured: baseline and 6 months
Plasma B-type Natriuretic Peptide (BNP) at Baseline
Plasma B-type Natriuretic Peptide (BNP) measured at basline
Measured: Baseline
Plasma B-type Natriuretic Peptide (BNP) at 6 Months
Plasma B-type Natriuretic Peptide (BNP)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jul 2009

First posted15 Feb 2006 (estimated)
Study startJan 2007
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00292162
Sponsor's protocol ID: 05/S0704/47
Status last verified: May 2012
First submitted: 14 Feb 2006
Last updated: 1 Jun 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 21051458

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease

All Chronic Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure
ClinicalTrials.gov ID: NCT00292162
Acronym / sponsor ID: 05/S0704/47
Conditions: Chronic Heart Failure, Atrial Fibrillation
Keywords: Chronic Heart Failure, Atrial Fibrillation, Radiofrequency Ablation
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: NHS Greater Glasgow and ClydeUniversity, hospital or other
Study start: Jan 2007
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 15 Feb 2006 (estimated)
Results: Posted 1 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
medical therapy	Active comparator	Drug: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril, Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol, Drug: Aldosterone Antagonists - spironolactoneStandard 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	Procedure: radiofrequency ablationIsolation of the pulmonary veins using radiofrequency ablation

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
radiofrequency ablationAlso: radiofrequency ablation (RFA), pulmonary vein isolation (PVI)isolation of the pulmonary veins with radiofrequency ablation (RFA)	Procedure or surgery	Radiofrequency ablation (RFA)
ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinoprilEvidence based treatment for heart failure. Dose and type will depend on patient tolerability.	Drug	medical therapy
Beta Blocker (BB) - metoprolol, bisoprolol, carvedilolEvidence based treatment for heart failure. Dose and type will depend on patient tolerance.	Drug	medical therapy
Aldosterone Antagonists - spironolactoneEvidence based treatment for heart failure. Dose and type will depend on patient to treatment.	Drug	medical therapy

Primary outcome

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

3 secondary outcomes

Plasma B-type Natriuretic Peptide (BNP)
Time frame: baseline and 6 months
Plasma B-type Natriuretic Peptide (BNP) at Baseline
Time frame: Baseline
Plasma B-type Natriuretic Peptide (BNP) at 6 Months
Time frame: 6 months

Results and safety

Results posted to the registry on 1 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medical Therapy	19	18
Radiofrequency Ablation	22	20

Primary outcome: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%

Time frame: baseline and 6 months. Mean (Standard Deviation). Unit: percentage of blood ejected in one beat

Measure	Medical Therapy n = 19	Radiofrequency Ablation n = 19
Value	2.8 (6.8)	4.5 (11.1)

Population analysed: 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

Primary outcome: Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)

Time frame: Baseline. Mean (Standard Deviation). Unit: percentage of blood ejected in one beat

Measure	Medical Therapy n = 19	Radiofrequency Ablation n = 19
Value	43 (10)	36 (12)

Primary outcome: Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months

Time frame: 6 months. Mean (Standard Deviation). Unit: percentage of blood ejected in one beat

Measure	Medical Therapy n = 19	Radiofrequency Ablation n = 19
Value	46 (7)	41 (11)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medical Therapy	0 of 19 (0%)	0 of 19 (0%)	Not reported
Radiofrequency Ablation	4 of 22 (18.2%)	0 of 22 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21051458MacDonald 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.

Related trials for Chronic Heart Failure

Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Derek T Connelly, MBChB principal investigator

Glasgow Royal Infirmary

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% (time frame: baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00292162, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.