Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT06184633
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DUTCH Weight Control in Atrial Fibrillation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'At 1 year follow-up', 'description': 'The 7 mutually exclusive outcomes hierarchically ranked from worst to best are:\n\n* Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)\\*\n* AF despite pulmonary vein isolation\n* AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation\n* Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* 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\n\n * When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.'}], 'secondaryOutcomes': [{'measure': 'Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit.', 'timeFrame': 'week 0 and 52', 'description': 'EHRA: European Heart Rythm Association\n\n1= 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'}, {'measure': 'Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.', 'timeFrame': 'week 0 and 52', '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.\n\nLEVEL 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'}, {'measure': 'Number of hospitalizations because of an AF recurrence.', 'timeFrame': 'week 0-52'}, {'measure': 'Number of unscheduled hospital visits because of adverse events of AAD.', 'timeFrame': 'week 0-52'}, {'measure': 'Number of scheduled electrical cardioversions.', 'timeFrame': 'week 0-52'}, {'measure': 'Number of unscheduled electrical cardioversions.', 'timeFrame': 'week 0-52'}, {'measure': 'Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).', 'timeFrame': 'week 0-52'}, {'measure': 'Total number of unscheduled cardioverions.', 'timeFrame': 'week 0-52'}, {'measure': 'Change in waist circumference, measured in cm', 'timeFrame': 'week 0 and 52'}, {'measure': 'Change in weight, measured in % and kg', 'timeFrame': 'week 0 and 52'}, {'measure': 'Change in BMI, measured in kg/m2', 'timeFrame': 'week 0 and 52'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Obesity', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'Quantify the effect of an innovative weight loss management on rhythm control.', 'detailedDescription': 'Rationale: Weight reduction promotes reversed atrial remodeling in obese AF patients.\n\nObjective: Quantify the effect of an innovative weight loss management on rhythm control.\n\nStudy design: Multi-center, double-blind, randomized, parallel group, placebo-controlled trial of semaglutide 2.4 mg versus placebo.\n\nStudy population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion.\n\nIntervention: 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.\n\nMain 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:\n\n* Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)\\*\n* AF despite pulmonary vein isolation\n* AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation\n* Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* 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\n\n * When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -\n* Age ≥ 18\n* Obesity, as defined as:\n\n * BMI ≥ 30 kg/m2, or\n * 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)\n* Scheduled ECV\n* Written informed consent\n\nExclusion Criteria:\n\n* Permanent AF\n* Secondary AF, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery\n* Current or previous treatment with amiodaron\n* HbA1c ≥ 48 mmol/L, \\<3 months prior to randomization\n* History of diabetes mellitus type 1 or 2\n* Prior bariatric surgery\n* Use of other anti-obesity medication, \\<3 months prior to enrollment\n* Contra-indication for, or prior use of a GLP1-receptor agonist\n* History of chronic pancreatitis or acute pancreatitis \\<6 months\n* Acute coronary syndrome \\<6 months\n* Severe (grade III) valvular disease\n* eGFR \\<30 mL/min/1.73m2\n* Heart failure NYHA class III-IV\n* Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)\n* 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.\n* Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.'}, 'identificationModule': {'nctId': 'NCT06184633', 'acronym': 'DUTCH-WAIST', 'briefTitle': 'DUTCH Weight Control in Atrial Fibrillation Study', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'U1111-1275-9989'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Semaglutide injections + combined lifestyle intervention', 'interventionNames': ['Drug: Semaglutide 3.2 MG/ML']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Semaglutide injections + combined lifestyle intervention', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Semaglutide 3.2 MG/ML', 'type': 'DRUG', 'description': 'Intervention arm receives semaglutide in addition to combined lifestyle intervention', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Control arm receives placebo in addition to combined lifestyle intervention', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'centralContacts': [{'name': 'Leonard Voorhout, MSc', 'role': 'CONTACT', 'email': 'lvoorhout@rijnstate.nl', 'phone': '+31650818296'}], 'overallOfficials': [{'name': 'Ron Pisters, dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardioresearch and principal investigator, dr. R. Pisters', 'investigatorFullName': 'Ron Pisters', 'investigatorAffiliation': 'Rijnstate Hospital'}}}}