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DUTCH Weight Control in Atrial Fibrillation Study

RECRUITINGPhase 4Sponsored by Rijnstate Hospital
Actively Recruiting
PhasePhase 4
SponsorRijnstate Hospital
Started2024-07-21
Est. completion2026-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

Atrial FibrillationHeart DiseaseObesityWeight Loss

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