NCT06184633Active, not recruitingPhase 4
DUTCH Weight Control in Atrial Fibrillation Study
DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
Quantify the effect of an innovative weight loss management on rhythm control.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 14 Dec 2023
- Start date
- 21 Jul 2024
- Primary completion date
- 10 Apr 2027
- Lead sponsor
- Rijnstate Hospital
- Diseases
- Obesity, Atrial fibrillation
- NCT number
- NCT06184633
- EU CT number
- 2022-501392-81-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 280
- From 21 Jul 2024 to the primary completion date, 10 Apr 2027
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous treatment with amiodaron
- Prior bariatric surgery
- Use of other anti-obesity medication, \<3 months prior to enrollment
- Contra-indication for, or prior use of a GLP1-receptor agonist
- Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)
Other illness
- Secondary AF, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery
- History of diabetes mellitus type 1 or 2
- History of chronic pancreatitis or acute pancreatitis \<6 months
- Acute coronary syndrome \<6 months
- Severe (grade III) valvular disease
- Heart failure NYHA class III-IV
- 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.
Lab values
- HbA1c ≥ 48 mmol/mol, \<3 months prior to randomization
- eGFR \<30 mL/min/1.73m2
Other
- Permanent AF
- Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest Ziekenhuisgroep Stichting Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Active, not recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Stichting Rijnstate Ziekenhuis Coordinator of this site? Confirm its status | Arnhem | Netherlands | Active, not recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Active, not recruiting |
| Deventer Ziekenhuis Coordinator of this site? Confirm its status | Deventer | Netherlands | Active, not recruiting |
| Slingeland Ziekenhuis Coordinator of this site? Confirm its status | Doetinchem | Netherlands | Active, not recruiting |
| Treant Ziekenhuiszorg Stichting Coordinator of this site? Confirm its status | Emmen | Netherlands | Active, not recruiting |
| Admiraal De Ruyter Ziekenhuis B.V. Coordinator of this site? Confirm its status | Goes | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Stichting Martini Ziekenhuis Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Spaarne Gasthuis Stichting Coordinator of this site? Confirm its status | Haarlem | Netherlands | Active, not recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Heerlen | Netherlands | Active, not recruiting |
| Medisch Centrum Leeuwarden B.V. Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Active, not recruiting |
| Alrijne Zorggroep Stichting Coordinator of this site? Confirm its status | Leiderdorp | Netherlands | Active, not recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Active, not recruiting |
| Canisius-Wilhelmina Hospital Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Bravis Ziekenhuis Coordinator of this site? Confirm its status | Roosendaal | Netherlands | Active, not recruiting |
| Medical Center Haaglanden Coordinator of this site? Confirm its status | 's-Gravenhage | Netherlands | Active, not recruiting |
| Haga Hospital Coordinator of this site? Confirm its status | 's-Gravenhage | Netherlands | Active, not recruiting |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Active, not recruiting |
| Diakonessenhuis Stichting Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
| Maxima Medisch Centrum Coordinator of this site? Confirm its status | Veldhoven | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.