Weight loss management for patients with atrial fibrillation

DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial

This study is testing if a weight loss medication called semaglutide can help adults with obesity and new atrial fibrillation manage their heart rhythm better than a placebo.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rijnstate Hospital (Academic / other)
• Locations: 1 site (Arnhem, Gelderland)
• Trial ID: NCT06184633 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effects of semaglutide, a weight loss medication, on rhythm control in adults with obesity and newly diagnosed persistent atrial fibrillation. The study is designed as a multi-center, double-blind, randomized, parallel group, placebo-controlled trial, comparing semaglutide to a placebo while both groups receive standard obesity treatment and cardiology follow-up. The primary endpoint will assess various clinical outcomes related to atrial fibrillation and weight management over a 12-month period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic, newly detected persistent atrial fibrillation and obesity.

Not a fit: Patients with permanent atrial fibrillation or those with certain contraindications, such as a history of diabetes or prior bariatric surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new approach to managing atrial fibrillation in obese patients through effective weight loss.

How similar studies have performed: While the specific combination of semaglutide and atrial fibrillation management is novel, previous studies have shown that weight loss can positively impact atrial fibrillation outcomes.

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.

Where this trial is running

Arnhem, Gelderland

• Rijnstate Hospital — Arnhem, Gelderland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Ron Pisters, dr. — Rijnstate Hospital
• Study coordinator: Leonard Voorhout, MSc

Conditions Atrial Fibrillation; Obesity; Weight Loss