Study on Semaglutide for Achieving Sinus Rhythm in Patients with Obesity and Persistent Atrial Fibrillation

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Semaglutide on individuals with Atrial Fibrillation and Obesity. Atrial Fibrillation, often referred to as AF, is a condition where the heart beats irregularly and can lead to various complications. Obesity is a condition characterized by excessive body weight, which can contribute to health issues like heart disease. The medication being tested, Semaglutide, is administered as a solution for injection and is being compared to a placebo to evaluate its effectiveness.

The purpose of the study is to determine if Semaglutide can help achieve a normal heart rhythm, known as sinus rhythm, in patients with obesity and newly detected, symptomatic persistent atrial fibrillation. Participants in the study will receive either Semaglutide or a placebo once a week for a period of one year. Throughout the study, the health and progress of the participants will be monitored to assess the impact of the treatment on their heart rhythm and overall health.

During the study, various health parameters will be observed, including changes in symptoms related to atrial fibrillation, quality of life, and weight. The study will also track the number of hospital visits and any changes in blood pressure, cholesterol levels, and other health indicators. The goal is to gather comprehensive data on how Semaglutide affects individuals with atrial fibrillation and obesity over the course of the study.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, presence of atrial fibrillation, and obesity.

Written informed consent is required to participate.

2 initial assessment

An initial assessment is conducted to record baseline measurements such as weight, waist circumference, blood pressure, and other health indicators.

This assessment helps in tracking changes over the course of the study.

3 medication administration

Participants receive a weekly subcutaneous injection of semaglutide at a dose of 2.4 mg or a placebo.

The medication is administered as a solution for injection.

4 follow-up visits

Regular follow-up visits are scheduled to monitor health status and any changes in symptoms.

These visits include assessments of atrial fibrillation symptoms, quality of life, and other health metrics.

5 12-month evaluation

At the 12-month mark, a comprehensive evaluation is conducted to assess the rhythm status of the heart and any changes in health indicators.

The primary focus is on achieving sinus rhythm and evaluating any adverse events.

6 final assessment

A final assessment is performed to measure changes in weight, waist circumference, blood pressure, and other health parameters.

The study aims to determine the effectiveness of semaglutide in managing atrial fibrillation and related health conditions.

Who Can Join the Study?

You must have symptomatic, first detected persistent atrial fibrillation (AF), which means your heart has an irregular beat that was noticed for the first time no more than 6 months before joining the study.
You must be 18 years old or older.
You must have obesity, which means a Body Mass Index (BMI) of 30 or higher. If your BMI is 27 or higher, you can still join if you have at least one other health issue related to weight, like high blood pressure, high cholesterol, sleep problems, or heart disease.
You must be scheduled for an electrical cardioversion (ECV), a procedure to help your heart beat normally.
You must provide written informed consent, which means you agree to participate after understanding the study details.

Who Cannot Join the Study?

Patients who do not have obesity cannot participate. Obesity means having a body weight that is higher than what is considered healthy for a given height.
Patients who do not have atrial fibrillation cannot participate. Atrial fibrillation is a condition where the heart beats in an irregular and often rapid manner.
Patients who have not experienced symptomatic persistent atrial fibrillation cannot participate. This means the irregular heartbeats have been ongoing and are causing noticeable symptoms.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Frisius	Heerenveen	The Netherlands
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Amphia Hospital	Breda	The Netherlands
Diakonessenhuis Stichting	Utrecht	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Alrijne Zorggroep Stichting	Leiderdorp	The Netherlands
Deventer Ziekenhuis	Deventer	The Netherlands
Medical Center Haaglanden	Leidschendam	The Netherlands
Stichting Treant Ziekenhuiszorg	Emmen	The Netherlands
Bravis Ziekenhuis	Roosendaal	The Netherlands
Slingeland Ziekenhuis	Doetinchem	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Uidgaihdeofb Mjskkyi Ckczkov Grulbccob	Groningen	The Netherlands
Sghruxpkc Mliemhz Zhrvjakynt	Groningen	The Netherlands
Aypvxfpr Dw Rflnnv Zelovmpfke Bgqu	Goes	The Netherlands
Axwbnlcwo Upx	Amsterdam	The Netherlands
Rlsfsohnq Zmdjvqknlr Sxcjtcjpc	Arnhem	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.06.2024

Trial locations

Investigated drugs:

Semaglutide

Semaglutide: This medication is used in the trial to help control weight in patients with obesity. It is given once a week through an injection under the skin. The goal is to see if it can help patients with a heart condition called atrial fibrillation (AF) return to a normal heart rhythm after one year.

Atrial fibrillation – Atrial fibrillation is a common heart rhythm disorder where the heart beats irregularly and often rapidly. This condition can lead to poor blood flow and may cause symptoms such as palpitations, shortness of breath, and fatigue. It often starts with brief episodes that become longer and more persistent over time. The irregular heartbeats can lead to the formation of blood clots, which may travel to other parts of the body. Over time, atrial fibrillation can weaken the heart and lead to heart failure. It is often associated with other heart-related conditions and can vary in severity and frequency.

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically measured using the Body Mass Index (BMI), where a BMI of 30 or higher is considered obese. Obesity develops over time due to a combination of genetic, behavioral, and environmental factors. It can lead to various health issues, including heart disease, diabetes, and joint problems. The condition often progresses as weight gain continues, leading to increased health risks. Managing obesity involves lifestyle changes and addressing underlying causes to prevent further complications.

Trial ID:

2022-501392-81-00

Protocol code:

2022-501392-81-00

NCT ID:

NCT06184633

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Semaglutide for Achieving Sinus Rhythm in Patients with Obesity and Persistent Atrial Fibrillation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?