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Trial · Interventional

Active, not recruitingPhase 4Registry data

DUTCH Weight Control in Atrial Fibrillation Study

Short name DUTCH-WAIST

NCTNCT06184633 (opens ClinicalTrials.gov in a new tab)Other idU1111-1275-9989
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
280 participants (estimated)
Sponsor
Rijnstate Hospital · Other
Design
Randomized · Triple masking
Countries
1 country

Netherlands

Start
21 Jul 2024
Primary completion
10 Apr 2027 (estimated)
Completion
1 May 2027 (estimated)
First posted
28 Dec 2023
Last update posted
1 Oct 2026
Conditions
Atrial Fibrillation · Obesity · Weight Loss

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025202620272028
  1. Ph 4

    DUTCH-WAIST

    NCT06184633

    21 Jul 2024 to est. 1 May 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Semaglutide 3.2 MG/MLDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Intervention

    Semaglutide injections + combined lifestyle intervention

  • Placebo comparator

    Placebo

    Placebo Semaglutide injections + combined lifestyle intervention

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Time frame · At 1 year follow-up

    Registry description

    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.

Secondary outcomes(11)

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

    Time frame · week 0 and 52

    Registry description

    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

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

    Time frame · week 0 and 52

    Registry description

    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

  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

  5. Number of scheduled electrical cardioversions.

    Time frame · week 0-52

  6. Number of unscheduled electrical cardioversions.

    Time frame · week 0-52

  7. Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).

    Time frame · week 0-52

  8. Total number of unscheduled cardioverions.

    Time frame · week 0-52

  9. Change in waist circumference, measured in cm

    Time frame · week 0 and 52

  10. Change in weight, measured in % and kg

    Time frame · week 0 and 52

  11. Change in BMI, measured in kg/m2

    Time frame · week 0 and 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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/mol, \<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.

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