DUTCH Weight Control in Atrial Fibrillation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide 3.2 MG/ML, Placebo.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Obesity, Weight Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial
Overview
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.
Interventions
- Drug Semaglutide 3.2 MG/ML
Intervention arm receives semaglutide in addition to combined lifestyle intervention - Drug Placebo
Control arm receives placebo in addition to combined lifestyle intervention
Primary outcome measures
- 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]
Secondary outcome measures (11)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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/L, <3 months prior to randomization
- History of diabetes mellitus type 1 or 2
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Rijnstate Hospital — Arnhem
Identifiers
NCT: NCT06184633 · U1111-1275-9989