RecruitingPhase 4NCT06184633

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


Sponsor

Rijnstate Hospital

Enrollment

280 participants

Start Date

Jul 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Quantify the effect of an innovative weight loss management on rhythm control.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria16

  • 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.

Interventions

DRUGSemaglutide 3.2 MG/ML

Intervention arm receives semaglutide in addition to combined lifestyle intervention

DRUGPlacebo

Control arm receives placebo in addition to combined lifestyle intervention


Locations(1)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

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NCT06184633


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