Atrial FibrillationPhase 3NCT00130975
Candesartan in the Prevention of Relapsing Atrial Fibrillation
A Phase 3 study testing Candesartan in people with Atrial Fibrillation, run by Asker & Baerum Hospital at 2 sites in Norway.
Trial summary
The purpose of this study is to test the hypothesis that treatment with the angiotensin II type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation after electrical cardioversion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Candesartan
- How many people
- 200 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2001to Sep 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with atrial fibrillation, diagnosed electrocardiographically, of more than 48 hours duration in whom direct current (DC) cardioversion is planned.
Who cannot join
- Patients with a history of known hypersensitivity or contraindication to any angiotensin II receptor blocker or any angiotensin-converting enzyme (ACE) inhibitor.
- Patients currently receiving an ACE inhibitor or angiotensin II antagonist because of heart failure or other strong indication.
- Patients currently receiving any antiarrhythmic medication including sotalol. Other beta-blockers will not be regarded as specific antiarrhythmic agents.
- Significant renal artery stenosis and any medical condition in which administration of a vasodilator is contraindicated; serum creatinine > 225 micromol/L; or serum potassium > 5.5 mmol/L; or serum sodium < 128 mmol/L.
- Patients with severe hepatic dysfunction.
- Life-limiting disease or substance abuse which may affect participation.
Show all 12Show fewer
- Patients unwilling to participate.
- Patients who have previously undergone DC cardioversion for atrial fibrillation within the last month.
- Thyrotoxicosis.
- Patients with a systolic blood pressure of < 100 mm Hg.
- Hypertensive patients requiring intensified treatment prior to DC cardioversion.
- Pregnancy or lactation.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ulleval University Hospital
Oslo, 0407
Asker & Baerum Hospital
Rud, 1309
About this study
The purpose of this study is to test the hypothesis that treatment with the angiotensin II type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation after electrical cardioversion.
Read the detailed description
Background: The most effective procedure to restore sinus rhythm in patients with persistent atrial fibrillation (AF) is electrical cardioversion, but AF recurs in 60-80% of the patients during the first year. AF is associated with electrical and anatomical remodelling of the atria, and angiotensin II is involved in the remodelling process. Studies have indicated that the angiotensin II type 1 receptor antagonist candesartan may counteract both electrical and anatomical remodelling induced by AF. The investigators therefore hypothesised that treatment with candesartan may reduce the recurrence rate of AF after electrical cardioversion.
Study design: 171 patients with persistent AF scheduled for electrical cardioversion are randomised in a double blind, placebo-controlled study. The patients receive tablets of candesartan 8 mg or matching placebo once daily for 3-6 weeks before cardioversion, and candesartan 16 mg or matching placebo once daily for 6 months after cardioversion. The study medication is discontinued if electrical cardioversion is unsuccessful or if AF recurrence is documented. Primary endpoint is recurrence of AF. Clinical, electrocardiographic, echocardiographic and biochemical markers will be analysed.
- Conditions
- Atrial Fibrillation
- Being tested
- Candesartan
- Keywords
- Atrial fibrillation., Cardioversion., Recurrence., Candesartan.
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation
Secondary outcomes (1)
Time to recurrence of atrial fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startApr 2001
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Asker & Baerum Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Ost, Ullevaal University Hospital, AstraZeneca
- Investigators
- Arnljot Tveit, MD, Principal investigator, Asker & Baerum Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130975
- Sponsor's protocol ID
- CAPRAF
- Status last verified
- Jan 2007
- First submitted
- 16 Aug 2005
- Last updated
- 4 Jan 2007
- Results posted
- No
Publications
Tveit A, Grundvold I, Olufsen M, Seljeflot I, Abdelnoor M, Arnesen H, Smith P. Candesartan in the prevention of relapsing atrial fibrillation. Int J Cardiol. 2007 Aug 9;120(1):85-91. doi: 10.1016/j.ijcard.2006.08.086. Epub 2006 Nov 17.
PubMed 17113170Horjen AW, Seljeflot I, Berge T, Smith P, Arnesen H, Tveit A. Effect of sinus rhythm restoration on markers of thrombin generation in atrial fibrillation. Thromb J. 2017 Dec 28;15:30. doi: 10.1186/s12959-017-0153-1. eCollection 2017.
PubMed 29299030
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candesartan in the Prevention of Relapsing Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00130975
- Acronym / sponsor ID
- CAPRAF
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation., Cardioversion., Recurrence., Candesartan.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Asker & Baerum HospitalUniversity, hospital or other
- Collaborators
- Helse Ost, Ullevaal University Hospital, AstraZeneca
- Study start
- Apr 2001
- Study completion
- Sep 2005
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the hypothesis that treatment with the angiotensin II type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation after electrical cardioversion.
Detailed description
Background: The most effective procedure to restore sinus rhythm in patients with persistent atrial fibrillation (AF) is electrical cardioversion, but AF recurs in 60-80% of the patients during the first year. AF is associated with electrical and anatomical remodelling of the atria, and angiotensin II is involved in the remodelling process. Studies have indicated that the angiotensin II type 1 receptor antagonist candesartan may counteract both electrical and anatomical remodelling induced by AF. The investigators therefore hypothesised that treatment with candesartan may reduce the recurrence rate of AF after electrical cardioversion.
Study design: 171 patients with persistent AF scheduled for electrical cardioversion are randomised in a double blind, placebo-controlled study. The patients receive tablets of candesartan 8 mg or matching placebo once daily for 3-6 weeks before cardioversion, and candesartan 16 mg or matching placebo once daily for 6 months after cardioversion. The study medication is discontinued if electrical cardioversion is unsuccessful or if AF recurrence is documented. Primary endpoint is recurrence of AF. Clinical, electrocardiographic, echocardiographic and biochemical markers will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with atrial fibrillation, diagnosed electrocardiographically, of more than 48 hours duration in whom direct current (DC) cardioversion is planned.
Key exclusion criteria (12 listed)
- Patients with a history of known hypersensitivity or contraindication to any angiotensin II receptor blocker or any angiotensin-converting enzyme (ACE) inhibitor.
- Patients currently receiving an ACE inhibitor or angiotensin II antagonist because of heart failure or other strong indication.
- Patients currently receiving any antiarrhythmic medication including sotalol. Other beta-blockers will not be regarded as specific antiarrhythmic agents.
- Significant renal artery stenosis and any medical condition in which administration of a vasodilator is contraindicated; serum creatinine > 225 micromol/L; or serum potassium > 5.5 mmol/L; or serum sodium < 128 mmol/L.
- Patients with severe hepatic dysfunction.
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 |
|---|---|---|
| Candesartan | Drug | – |
Primary outcome
Recurrence of atrial fibrillation
1 secondary outcome
Time to recurrence of atrial fibrillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2007.
- Results publication: PubMed 17113170Tveit A, Grundvold I, Olufsen M, Seljeflot I, Abdelnoor M, Arnesen H, Smith P. Candesartan in the prevention of relapsing atrial fibrillation. Int J Cardiol. 2007 Aug 9;120(1):85-91. doi: 10.1016/j.ijcard.2006.08.086. Epub 2006 Nov 17.
- Derived from this study: PubMed 29299030Horjen AW, Seljeflot I, Berge T, Smith P, Arnesen H, Tveit A. Effect of sinus rhythm restoration on markers of thrombin generation in atrial fibrillation. Thromb J. 2017 Dec 28;15:30. doi: 10.1186/s12959-017-0153-1. eCollection 2017.
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Atrial Fibrillation (AF)
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.
Arnljot Tveit, MD principal investigator
Asker & Baerum Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candesartan in people with Atrial Fibrillation, run by Asker & Baerum Hospital at 2 sites in Norway.
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 1 inclusion and 12 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 4 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence of atrial fibrillation. 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 NCT00130975, which also lists 2 linked publications.
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 4 Jan 2007.