DUTCH Weight Control in Atrial Fibrillation Study (DUTCH-WAIST)

Rijnstate Hospital

Status and phase: Enrolling; Phase 4

Conditions: Weight Loss; Atrial Fibrillation; Obesity

Treatments: Drug: Semaglutide 3.2 MG/ML; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06184633

U1111-1275-9989

Details and patient eligibility

About

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

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

Semaglutide injections + combined lifestyle intervention

Treatment:

Drug: Semaglutide 3.2 MG/ML

Placebo

Placebo Comparator group

Description:

Placebo Semaglutide injections + combined lifestyle intervention

Treatment:

Drug: Placebo