Health TrialsbyHealthPanel

DUTCH Weight Control in Atrial Fibrillation Study

ConditionsAtrial FibrillationObesityWeight Loss
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRijnstate Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -

Age ≥ 18

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 1 year follow-up

Secondary outcomes

1

Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit.

EHRA: European Heart Rythm Association 1= no symptoms 2a= mild symptoms; Normal dialy activity not affected, symptoms not troublesome to patient 2b= moderate symptoms; Normal daily activity not affected but patient troubled by symptoms 3= severe symptoms; Normal daily activity affected 4= disabling symptoms; Normal daily activity discontinued

Time frame
week 0 and 52
2

Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.

Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems

Time frame
week 0 and 52
3

Number of hospitalizations because of an AF recurrence.

Time frame
week 0-52
4

Number of unscheduled hospital visits because of adverse events of AAD.

Time frame
week 0-52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rijnstate Hospital

Lead sponsor

Source ClinicalTrials.gov
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