Atrial FibrillationPhase 4DUTCH-WAISTNCT06184633
DUTCH Weight Control in Atrial Fibrillation Study
A Phase 4 study testing Semaglutide 3.2 MG/ML in people with Atrial Fibrillation and Obesity, run by Rijnstate Hospital at 20 sites in Netherlands.
Trial summary
Quantify the effect of an innovative weight loss management on rhythm control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Obesity, Weight Loss
- What is being tested?
- Semaglutide 3.2 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 20 sitesNetherlands
- Study dates
- 21 Jul 2024to 1 May 2027
- 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
- Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -
- Age ≥ 18
- Obesity, as defined as:
- BMI ≥ 30 kg/m2, or
- BMI ≥27 kg/m2 with the presence of at least one weight related comorbidity (treated or untreated, e.g. hypertension, dyslipidaemia, obstructive sleep apnea, cardiovascular disease)
- Scheduled ECV
- Written informed consent
Who cannot join
- Permanent AF
- Secondary AF, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery
- Current or previous treatment with amiodaron
- HbA1c ≥ 48 mmol/mol, <3 months prior to randomization
- History of diabetes mellitus type 1 or 2
- Prior bariatric surgery
Show all 16Show fewer
- Use of other anti-obesity medication, <3 months prior to enrollment
- Contra-indication for, or prior use of a GLP1-receptor agonist
- History of chronic pancreatitis or acute pancreatitis <6 months
- Acute coronary syndrome <6 months
- Severe (grade III) valvular disease
- eGFR <30 mL/min/1.73m2
- Heart failure NYHA class III-IV
- Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)
- Any condition or therapy, which would make the participant unsuitable for the study (e.g. vulnerable, non-compliance) or life-expectancy <12 months, as judged by the treating physician.
- Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Netherlands20 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Noordwest Ziekenhuisgroep
Alkmaar
Amsterdam UMC
Amsterdam
Rijnstate Hospital
Arnhem, Gelderland
Amphia Ziekenhuis
Breda
Deventer Ziekenhuis
Deventer
Slingeland Ziekenhuis
Doetinchem
Máxima MC
Eindhoven
Treant Zorggroep
Emmen
Admiraal de Ruyter Ziekenhuis
Goes
Martini Ziekenhuis
Groningen
Universitair Medisch Centrum Groningen
Groningen
Spaarne Gasthuis
Haarlem
Zuyderland Medisch Centrum
Heerlen
Frisius MC
Leeuwarden
Maastricht UMC+
Maastricht
Bravis ziekenhuis
Roosendaal
Haaglanden Medisch Centrum
The Hague
HagaZiekenhuis
The Hague
Diakonessenhuis
Utrecht
About this study
Official title: DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial
Quantify the effect of an innovative weight loss management on rhythm control.
Read the detailed description
Rationale: Weight reduction promotes reversed atrial remodeling in obese AF patients.
Objective: Quantify the effect of an innovative weight loss management on rhythm control.
Study design: Multi-center, double-blind, randomized, parallel group, placebo-controlled trial of semaglutide 2.4 mg versus placebo.
Study population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion.
Intervention: semaglutide 2.4 mg subcutaneous (s.c.) once weekly (index) compared to placebo (control), at the background of standard obesity treatment (combined lifestyle intervention) and cardiology follow-up management in both arms.
Main study parameters/endpoints: The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 7 mutually exclusive outcomes hierarchically ranked from worst to best are:
- Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)*
- AF despite pulmonary vein isolation
- AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation
- Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation
- When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.
- Conditions
- Atrial Fibrillation, Obesity, Weight Loss
- Being tested
- Semaglutide 3.2 MG/ML, Placebo
- Medical subject headings
- Atrial Fibrillation, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 3.2 MG/MLDrug
Intervention arm receives semaglutide in addition to combined lifestyle intervention
PlaceboDrug
Control arm receives placebo in addition to combined lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Semaglutide injections + combined lifestyle intervention Receives: Drug: Semaglutide 3.2 MG/ML |
| Placebo | Placebo comparator | Placebo Semaglutide injections + combined lifestyle intervention Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome
The 7 mutually exclusive outcomes hierarchically ranked from worst to best are:
- Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)*
- AF despite pulmonary vein isolation
- AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation
- Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation
- When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.
Measured: At 1 year follow-up
Secondary outcomes (11)
Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit.
EHRA: European Heart Rythm Association
1= no symptoms 2a= mild symptoms; Normal dialy activity not affected, symptoms not troublesome to patient 2b= moderate symptoms; Normal daily activity not affected but patient troubled by symptoms 3= severe symptoms; Normal daily activity affected 4= disabling symptoms; Normal daily activity discontinued
Measured: week 0 and 52
Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.
Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems
Measured: week 0 and 52
Number of hospitalizations because of an AF recurrence.
Measured: week 0-52
Number of unscheduled hospital visits because of adverse events of AAD.
Measured: week 0-52
Number of scheduled electrical cardioversions.
Measured: week 0-52
Number of unscheduled electrical cardioversions.
Measured: week 0-52
Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).
Measured: week 0-52
Total number of unscheduled cardioverions.
Measured: week 0-52
Change in waist circumference, measured in cm
Measured: week 0 and 52
Change in weight, measured in % and kg
Measured: week 0 and 52
Change in BMI, measured in kg/m2
Measured: week 0 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start21 Jul 2024
- Primary completion10 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Pisters, Rijnstate Hospital
- Investigators
- Ron Pisters, dr., Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184633
- Sponsor's protocol ID
- U1111-1275-9989
- Acronym
- DUTCH-WAIST
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06184633
- Acronym / sponsor ID
- DUTCH-WAIST / U1111-1275-9989
- Conditions
- Atrial Fibrillation, Obesity, Weight Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 21 Jul 2024 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 28 Dec 2023 (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.
Quantify the effect of an innovative weight loss management on rhythm control.
Detailed description
Rationale: Weight reduction promotes reversed atrial remodeling in obese AF patients.
Objective: Quantify the effect of an innovative weight loss management on rhythm control.
Study design: Multi-center, double-blind, randomized, parallel group, placebo-controlled trial of semaglutide 2.4 mg versus placebo.
Study population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion.
Intervention: semaglutide 2.4 mg subcutaneous (s.c.) once weekly (index) compared to placebo (control), at the background of standard obesity treatment (combined lifestyle intervention) and cardiology follow-up management in both arms.
Main study parameters/endpoints: The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 7 mutually exclusive outcomes hierarchically ranked from worst to best are:
- Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)*
- AF despite pulmonary vein isolation
- AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation
- Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
- Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation
- When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Semaglutide 3.2 MG/MLSemaglutide injections + combined lifestyle intervention |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Semaglutide injections + combined lifestyle intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -
- Age ≥ 18
- Obesity, as defined as:
- Scheduled ECV
- Written informed consent
Key exclusion criteria (16 listed)
- Permanent AF
- Secondary AF, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery
- Current or previous treatment with amiodaron
- HbA1c ≥ 48 mmol/mol, <3 months prior to randomization
- History of diabetes mellitus type 1 or 2
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 |
|---|---|---|
| Semaglutide 3.2 MG/MLIntervention arm receives semaglutide in addition to combined lifestyle intervention | Drug | Intervention |
| PlaceboControl arm receives placebo in addition to combined lifestyle intervention | Drug | Placebo |
Primary outcome
The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome
Time frame: At 1 year follow-up
The 7 mutually exclusive outcomes hierarchically ranked from worst to best are: * Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)* * AF despite pulmonary vein isolation * AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation * Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation * When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.
11 secondary outcomes
Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit.
Time frame: week 0 and 52
Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.
Time frame: week 0 and 52
Number of hospitalizations because of an AF recurrence.
Time frame: week 0-52
Number of unscheduled hospital visits because of adverse events of AAD.
Time frame: week 0-52
Number of scheduled electrical cardioversions.
Time frame: week 0-52
Number of unscheduled electrical cardioversions.
Time frame: week 0-52
Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).
Time frame: week 0-52
Total number of unscheduled cardioverions.
Time frame: week 0-52
Change in waist circumference, measured in cm
Time frame: week 0 and 52
Change in weight, measured in % and kg
Time frame: week 0 and 52
Change in BMI, measured in kg/m2
Time frame: week 0 and 52
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 1 Oct 2026.
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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. This study is not recruiting at the moment.
Ron Pisters, dr. principal investigator
Rijnstate Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide 3.2 MG/ML in people with Atrial Fibrillation and Obesity, run by Rijnstate Hospital at 20 sites in Netherlands.
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 7 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Netherlands. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome (time frame: At 1 year 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 1 Oct 2026.