Study of AP31969 compared to placebo to control heart rhythm in patients with atrial fibrillation

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What is this study about?

This clinical trial focuses on studying atrial fibrillation, which is an irregular and often rapid heart rhythm condition. The study will evaluate a new medication called AP31969, an experimental antiarrhythmic drug that aims to control heart rhythm. The main purpose is to assess how effectively AP31969 reduces the burden of atrial fibrillation compared to placebo.

The treatment involves taking AP31969 tablets orally for a period of 12 weeks. The medication will be provided as film-coated tablets in various dosage strengths. Some participants will receive the active medication, while others will receive placebo tablets that look identical to the real medication but contain no active substance.

During the study, participants will have their heart rhythm monitored continuously through special recording devices. The study will track how often atrial fibrillation episodes occur and how long they last. Participants will also complete questionnaires about their quality of life and symptoms related to their heart condition.

1 Initial assessment and device placement

You will receive an ECG patch device to measure your heart rhythm and confirm that your atrial fibrillation (irregular heartbeat) occurs between 1% and 90% of the time.

A loop recorder will be implanted under your skin to continuously monitor your heart rhythm during the study.

2 Random group assignment

You will be randomly assigned to receive either AP31969 tablets or placebo tablets (tablets without active medication).

The tablets in both groups look identical, and you will not know which type you are receiving.

3 Treatment period

The treatment period lasts for 12 weeks.

You will take the assigned tablets by mouth as instructed.

Your heart rhythm will be continuously monitored through the implanted loop recorder.

4 Monitoring and assessments

Your heart rhythm will be specifically analyzed from week 2 to week 12.

You will complete quality of life questionnaires at the start and at week 12.

Regular heart measurements (ECG) will be taken to monitor your heart’s electrical activity.

Any side effects will be recorded throughout the study period.

5 Final assessment

At week 12, you will have a final evaluation.

You will complete final questionnaires about your symptoms and quality of life.

A final ECG measurement will be taken.

Your overall response to the treatment will be assessed.

Who Can Join the Study?

Must be able and willing to give written permission to participate in the study
Must be 18 years of age or older
Must have atrial fibrillation confirmed by an ECG (a test that records the heart’s electrical activity)
Must have a history showing that atrial fibrillation occurs between 1-90% of the time
If currently experiencing atrial fibrillation, the episode must have started less than 7 days before screening
Must show atrial fibrillation occurring between 1% and 90% of the time when measured with a special heart monitoring patch
Must agree not to undergo any heart rhythm treatments outside of the study during the trial period
Must be willing to have a loop recorder (a small device that monitors heart rhythm) implanted under the skin
For women who can become pregnant and have a male partner: must use reliable birth control and not donate eggs from 4 weeks before starting the study until the follow-up visit
For men with female partners who can become pregnant: must use condoms and not donate sperm from screening until the follow-up visit
Women must not be pregnant or breastfeeding during the study

Who Cannot Join the Study?

Age below 18 years or above 65 years
Pregnancy or breastfeeding
History of severe allergic reactions to medications
Recent heart surgery (within the last 6 months)
Presence of heart valve disease (problems with heart valves)
Severe hypertension (high blood pressure that is not controlled with medication)
Active bleeding disorders
Severe liver disease
Severe kidney disease
Current participation in other clinical trials
Use of medications that could interact with the study drug
History of stroke (a condition where blood flow to the brain is interrupted)
Untreated thyroid disease (problems with thyroid gland function)
Severe heart failure (when heart cannot pump blood effectively)
History of drug or alcohol abuse within the past year
Mental conditions that could affect ability to follow study procedures
Life expectancy less than 1 year due to other medical conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Frisius	Heerenveen	The Netherlands
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD	Sofia	Bulgaria

Other Sites

Site Name	City	Country
Semmelweis University	Budapest	Hungary
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Klinikum Coburg GmbH	Coburg	Germany
Gottsegen National Cardiovascular Center	Budapest	Hungary
Specialized Hospital For Active Cardiology Treatement Cardiolife OOD	Varna	Bulgaria
Azienda Ulss 3 Serenissima	Venice	Italy
Heyj Hgadvgea	Hague	The Netherlands
Dnqotdpgymecmmqsjxtmklt chgxfs “veormzyoqtfnwgy Epzg	Sofia	Bulgaria
Ftopgsfmsn Inbqh Co Gjpvfb Otyveftk Mybywepg Pteswfjshpe	Milan	Italy
Azvi Glxeim Ocxbwgcn Mjexqszmcivlr Nisdwlnn	Milan	Italy
Stvxktztocx Plbzoasmq Zjtnur Ozwihm Zsrcrftaus Sqptjna Ufjphhtcdhett W Kgblhxqo	Cracow	Poland
Rulkqh Mowywlhboxh	Aarhus	Denmark
Uzlmhbbiin Oe Sovinv	Szeged	Hungary
Uzgazawmxw Hbtrwkry Mmzbbheyxd	Maastricht	The Netherlands
Aqaofey Uzymo Ssuqgsmif Lkhaic Ds Bqhhzbe	Bologna	Italy
Ubeyiqhmxt Mmxwvdw Cepzhp Hvuvnraycoqwkqtxj	Hamburg	Germany
Uqdbdixuuqkvxjvxa Davlf Sacph Dl Ftthhma	Ferrara	Italy
Mousbybis Nkzo Chjlte Lcxx	Varna	Bulgaria
Uishulfdlu Mqcismeoialr Hslnuttq Fic Apnyip Tqovsccrg Skxxk Grhkjb Ecn	Plovdiv	Bulgaria
Ssdeotb Ctqqxiv Cesrgq Sgntf W Zbmwqs	Zabrze	Poland
Brpaccdpql Iatvffxbfoxa Bxhmt Iegmkxcjeibry Kcsytc	Budapest	Hungary
Gyugvukylgch Cvdnnbt Mxuixbaa	Katowice	Poland
Bgrozyyqj Ereaznpwnnh Kyna	Zalaegerszeg	Hungary
Dncfalpz Zaohrrnoeu	Deventer	The Netherlands
Clvvlejn Gvrjoybcb Shcdjf	Bergamo	Italy
Ggvbwn Uuaawzihwj Fendtbsgt	Frankfurt	Germany
Aecsgygl Hghja Ok Plbjfw Stcb	Kedzierzyn-Kozle	Poland
Uznaghbrav Ov Pxsk	Pecs	Hungary
Ggsfhqlw Hagrzmsp	Hellerup	Denmark
Sefhnmu Epukatcu Oukxxb Kinjdr Et Rjlwbxmllluhff Itepwis	Sopron	Hungary
Rdbragnrd Zycgzigvcw Sbsatgkbq	Arnhem	The Netherlands
Syvnfeemk Mupifqe Zvdlribwer	Groningen	The Netherlands
Nagxzczc Ijhqluog Ktjatnenkhh Sjlqigk Kocpfpvkl Wlavfzhbadwf Pxwemuhvp Imxlhhte Beafciib	Warsaw	Poland
Jhvhclqphsfgemmzakvz Vxfpitcxc Hymgrda Gbac Kmkintdbtdnevufuzvzym	Szolnok	Hungary
Kvfaahtnboygtnigl Vgzcuiyvo Sepvl Bokpxak Krmxgv	Tatabanya	Hungary
Zmthnvcjiy Rnmtbadjjfms	Tiel	The Netherlands
Cnyzplj Mryzgmhl Kdjwfs Rduekn Bohhynkfrlnokb I Euv Ktcovmuktd Stf jb	Bydgoszcz	Poland
Snarhoe Ghatudqu	Hoofddorp	The Netherlands
Miukfm Mkmwsqg Cdwdcww	Veldhoven	The Netherlands
Oss Dib Mlw Sen z oqkm	Szczecin	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	01.09.2025
Denmark	Recruiting	01.09.2025
Germany	Recruiting	01.09.2025
Hungary	Recruiting	01.09.2025
Italy	Recruiting	01.09.2025
Poland	Recruiting	01.09.2025
The Netherlands	Recruiting	01.09.2025

Trial locations

Investigated Drugs:

AP31969 SULFATE

AP31969 is an investigational medication being studied for controlling heart rhythm in patients with atrial fibrillation (an irregular heartbeat condition). The medication is being tested to see if it can reduce how often and how long patients experience irregular heart rhythms. This is an experimental drug that is still being researched and does not yet have a common brand name.

A placebo (an inactive substance) is also used in this trial as a comparison to measure how well AP31969 works.

Atrial Fibrillation – A heart rhythm disorder where the upper chambers of the heart (atria) beat irregularly and often rapidly, out of coordination with the lower chambers. This condition occurs when the heart’s electrical signals become chaotic, causing an irregular heartbeat pattern. The irregular rhythm can cause blood to pool in the heart chambers, which affects how efficiently the heart pumps blood throughout the body. People with atrial fibrillation may experience heart palpitations, shortness of breath, and fatigue. The condition can be persistent, occurring continuously, or paroxysmal, where episodes come and go.

Trial ID:

2025-521377-14-00

Protocol code:

AP31969-M201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of AP31969 compared to placebo to control heart rhythm in patients with atrial fibrillation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?