DUTCH Weight Control in Atrial Fibrillation Study

Sponsor
Rijnstate Hospital
Study ID
NCT06184633
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide 3.2 MG/ML — DRUG
    Intervention arm receives semaglutide in addition to combined lifestyle intervention
  • Placebo — DRUG
    Control arm receives placebo in addition to combined lifestyle intervention

Study Details

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

Key Dates

Start date
Jul 21, 2024
Status verified
Sep 2024
Primary completion
May 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention
    Semaglutide injections + combined lifestyle intervention
  • Placebo Comparator: Placebo
    Placebo Semaglutide injections + combined lifestyle intervention

Primary Outcome Measure

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 ]

Central Contacts

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