Persistent Atrial FibrillationPhase 4PERIVERSION-2NCT07273994
Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation
A Phase 4 study testing Amiodarone Hydrochloride 200 MG and Amiodarone Hydrochloride 100 MG in people with Persistent Atrial Fibrillation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
--- The goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Amiodarone Hydrochloride 200 MG and Amiodarone Hydrochloride 100 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2025to Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 aged ≥ 18 years
- Documented persistent atrial fibrillation (≥ 7 days in duration)
- Electively referred for Electrical Cardioversion
- Signed informed consent.
Who cannot join
- Urgent electrical cardioversion
- Atrial fibrillation post-cardiac surgery
- Previous myocardial infarction
- New York Heart Association (NYHA) Class IV heart failure
- Left ventricular ejection fraction (LVEF) <45%
- Significant left ventricular hypertrophy (wall thickness ≥ 15mm)
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- Hyperthyroidism or hypothyroidism
- Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN)
- Allergy, intolerance, or known hypersensitivity to study medications
- Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women.
- Participation in another clinical trial involving investigational drugs
- Life expectancy less than 12 months
- Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
- Patients with contraindications to amiodarone, such as uncontrolled thyroid dysfunction, severe sinus bradycardia, second- or third-degree AV block without a pacemaker, and a history of amiodarone-induced pulmonary toxicity.
- Patients in whom chronic amiodarone treatment previously failed to maintain sinus rhythm
- Patients with abnormal baseline QTc (>450 ms in males and >470 in females) or abnormal ECG that precludes QTc assessment
- Patients requiring concomitant medications that have a higher risk of QTc prolongation.
- Patient do not have a smart mobile phone or do not know how to use it adequately.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Jose M Guerra, MD, PhD, +34 935565945, jguerra@santpau.cat
About this study
Official title: Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation
---
The goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. The main questions it aims to answer are:
Read more
- Can a reduced dose of amiodarone (100 mg/day) maintain sinus rhythm as effectively as the standard dose (200 mg/day) 12 months post electrical cardioversion?
- What are the adverse effects of the standard and reduced doses of amiodarone during 12 months post electrical cardioversion?
- How do genetic polymorphisms affect the efficacy and safety of amiodarone?
- How do amiodarone plasma levels correlate with the maintenance of sinus rhythm and genetic polymorphisms?
Researchers will compare the standard dose (200 mg/day) to the reduced dose (100 mg/day) to see if the reduced dose offers a better balance between efficacy and safety.
Participants will:
- Be treated with full dose amiodarone (200 mg/day) during the first month after electrical cardioversion.
- Be randomized to either continue with the full dose (200 mg/day) or switch to the reduced dose (100 mg/day).
The study is a multicenter, randomized clinical trial involving 312 patients with persistent AF after successful electrical cardioversion. Participants will be followed for 12-18 months to monitor the recurrence of AF and adverse effects.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Amiodarone Hydrochloride 200 MG, Amiodarone Hydrochloride 100 MG
- Keywords
- Atrial fibrillation, Electrical cardioversion, Amiodarone, Pharmacogenetics, Adverse effects
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone Hydrochloride 200 MGDrug
Patients will receive full amiodarone daily doses: 200 mg/day
Amiodarone Hydrochloride 100 MGDrug
Patients will receive amiodarone reduced daily doses: 100 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone full doses | Active comparator | Patients will receive amiodarone full doses (200 mg/day) (Usual dose) Receives: Drug: Amiodarone Hydrochloride 200 MG |
| Amiodarone reduced doses | Experimental | Patients will receive amiodarone reduced doses (100 mg/day) Receives: Drug: Amiodarone Hydrochloride 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of sinus rhythm
Number of patients mantaining sinus rhythm 12 months post electrical cardioversion
Measured: 12 months follow-up
Secondary outcomes (3)
Adverse effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 months follow-up
Polymorphisms
Association of the different assessed polymorphisms with the primary and first secondary outcome
Measured: 12 months follow-up
Plasma levels
Correlation of amiodarone plasma levels during follow-up with the maintenance of sinus rhythm
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273994
- Sponsor's protocol ID
- IIBSP-AMI-2024-33
- Other IDs
- Project PI023/1768, 2024-514113-35-00
- Acronym
- PERIVERSION-2
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07273994
- Acronym / sponsor ID
- PERIVERSION-2 / IIBSP-AMI-2024-33
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial fibrillation, Electrical cardioversion, Amiodarone, Pharmacogenetics, Adverse effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Dec 2025 (actual)
- 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 goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. The main questions it aims to answer are:
- Can a reduced dose of amiodarone (100 mg/day) maintain sinus rhythm as effectively as the standard dose (200 mg/day) 12 months post electrical cardioversion?
- What are the adverse effects of the standard and reduced doses of amiodarone during 12 months post electrical cardioversion?
- How do genetic polymorphisms affect the efficacy and safety of amiodarone?
- How do amiodarone plasma levels correlate with the maintenance of sinus rhythm and genetic polymorphisms?
Researchers will compare the standard dose (200 mg/day) to the reduced dose (100 mg/day) to see if the reduced dose offers a better balance between efficacy and safety.
Participants will:
- Be treated with full dose amiodarone (200 mg/day) during the first month after electrical cardioversion.
- Be randomized to either continue with the full dose (200 mg/day) or switch to the reduced dose (100 mg/day).
The study is a multicenter, randomized clinical trial involving 312 patients with persistent AF after successful electrical cardioversion. Participants will be followed for 12-18 months to monitor the recurrence of AF and adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone full doses | Active comparator | Drug: Amiodarone Hydrochloride 200 MGPatients will receive amiodarone full doses (200 mg/day) (Usual dose) |
| Amiodarone reduced doses | Experimental | Drug: Amiodarone Hydrochloride 100 MGPatients will receive amiodarone reduced doses (100 mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥ 18 years
- Documented persistent atrial fibrillation (≥ 7 days in duration)
- Electively referred for Electrical Cardioversion
- Signed informed consent.
Key exclusion criteria (18 listed)
- Urgent electrical cardioversion
- Atrial fibrillation post-cardiac surgery
- Previous myocardial infarction
- New York Heart Association (NYHA) Class IV heart failure
- Left ventricular ejection fraction (LVEF) <45%
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 |
|---|---|---|
| Amiodarone Hydrochloride 200 MGPatients will receive full amiodarone daily doses: 200 mg/day | Drug | Amiodarone full doses |
| Amiodarone Hydrochloride 100 MGPatients will receive amiodarone reduced daily doses: 100 mg/d | Drug | Amiodarone reduced doses |
Primary outcome
Maintenance of sinus rhythm
Time frame: 12 months follow-up
Number of patients mantaining sinus rhythm 12 months post electrical cardioversion
3 secondary outcomes
Adverse effects
Time frame: 12 months follow-up
Polymorphisms
Time frame: 12 months follow-up
Plasma levels
Time frame: 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amiodarone Hydrochloride 200 MG and Amiodarone Hydrochloride 100 MG in people with Persistent Atrial Fibrillation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 4 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose M Guerra, MD, PhD (+34 935565945, jguerra@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of sinus rhythm (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.