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
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.
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- 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