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
University Hospital Maastricht	Maastricht	The Netherlands
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD	Sofia	Bulgaria

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Klinikum Coburg GmbH	Coburg	Germany
MHAT National Heart Hospital EAD	Sofia	Bulgaria
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Ziekenhuis Rivierenland	Tiel	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Medcenter Nova Clinic Ltd.	Varna	Bulgaria
Azienda Ulss 3 Serenissima	Venice	Italy
One Day Med Sp. z o.o.	Szczecin	Poland
Specialized Hospital For Active Cardiology Treatement Cardiolife OOD	Varna	Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Semmelweis University	Budapest	Hungary
Belvarosi Egeszseghaz Kft.	Zalaegerszeg	Hungary
Deventer Ziekenhuis	Deventer	The Netherlands
Region Midtjylland	Aarhus	Denmark
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Gentofte Hospital	Hellerup	Denmark
Soproni Erzsebet Oktato Korhaz Es Rehabilitacios Intezet	Sopron	Hungary
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
Spaarne Gasthuis	Hoofddorp	The Netherlands
University Of Szeged	Szeged	Hungary
Ufqwhkpouv Mjcabwh Cbuvhp Hubiioewemqnzozbi	Hamburg	Germany
Rglehonvl Zppnpxdwgt Syavovnwo	Arnhem	The Netherlands
Slucceshh Mpytont Zvqzbfccgq	Groningen	The Netherlands
Bvwvgaurro Iqaeddkcaxiq Bbcoi Izrgkcujzfmak Kbmxga	Budapest	Hungary
Gaytkn Uforzzyotw Fgmlshkfh	Frankfurt	Germany
Aeazybr Ufyka Scqudskap Llvkpj Dx Bmkkrgh	Bologna	Italy

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.

Investigated diseases:

Atrial fibrillation

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?