Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression (DANWRAP)
The Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression
Obesity is an important risk factor for the development and progression of atrial fibrillation. Sustainable weight loss likely reduces the burden of atrial fibrillation, which has yet to be proven in adequately sized randomised trials.
In a national, multicentre randomised trial we will test, whether a sustainable weight loss of more than 10% reduces atrial fibrillation progression and burden in patients with symptomatic paroxysmal or early persistent atrial fibrillation and a body mass index ≥27 kg/m2. A total of 480 patients will be randomised in a 1:1 fashion to either a comprehensive weight loss programme of behavioural support, meal replacement and/or pharmacotherapy with a glucagon-like peptide-1 receptor agonist on top of standard care aiming at more than 10% weight loss or standard care alone. Standard care will include guideline-directed anticoagulant therapy for stroke prevention, rate and/or rhythm control treatment, and management of risk factors and underlying cardiovascular conditions. Patients in the standard care group will receive information on weight management, but no active treatment for weight loss. Patients will be enrolled during a period of two and a half years and will be followed for one year with an equal number of study visits in both study arms. All patients will receive a 14-day continuous electrocardiographic monitoring at baseline, four, eight, and 12 months.
The study endpoints will be assessed after a 4-months blanking period from month four to 12 to allow for weight loss. The primary endpoint will be a hierarchical composite of atrial fibrillation progression, symptom burden, and treatment escalation. Secondary endpoints will be a change in weight, total atrial fibrillation burden, quality of life, and metabolic and cardiovascular biomarkers from baseline to 12 months. Safety endpoints will be adverse events related to treatment with glucagon-like peptide-1 receptor agonists and weight loss. Endpoint adjudication will be blinded.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Axel Brandes, M.D.
- Número de telefone: +4579184491
- E-mail: Axel.Brandes@rsyd.dk
Estude backup de contato
- Nome: Eva Prescott, PhD
- E-mail: eva.irene.bossano.prescott@regionh.dk
Locais de estudo
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Copenhagen, Dinamarca
- University Hospital Bispebjerg and Frederiksberg
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Contato:
- Eva Prescott, PhD
- E-mail: eva.irene.bossano.prescott@regionh.dk
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Esbjerg, Dinamarca, 6700
- Esbjerg Hospital - University Hospital of Southern Denmark
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Contato:
- Axel Brandes, M.D.
- Número de telefone: +4579184491
- E-mail: Axel.Brandes@rsyd.dk
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Investigador principal:
- Axel Brandes, M.D.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion criteria:
- Symptomatic paroxysmal* or persistent** AF
- Sinus rhythm at inclusion (Visit 1)
- BMI ≥27 kg/m2
- Age>18 years
At least one 12-lead ECG or other single- or multiple-lead ECG device (e.g. Holter monitor-ing or ECG-providing wearables) documented episode during 6 months prior to inclusion
* Paroxysmal AF in this trial is defined as at least 2 episodes, either self-terminating or cardioverted within 7 days, during 6 months prior to in-clusion
**Persistent AF in this study is defined as the following:
- Duration of an AF episode >7 days and < 6 months
- Total documented AF history < 5 years
Exclusion criteria:
- Atrial flutter as the primary arrhythmia. (Patients with previous or isolated episodes of atrial flutter may be included, provided that AF is the dominant arrhythmia and the primary target of clinical management)
- Implanted electronic device (pacemaker/ICD/ICM)
- Type 1 diabetes or Type 2 diabetes on insulin treatment
- Severe heart failure (LVEF <40%)
- Inability to sign informed consent
- Severe kidney disease (eGFR<30)
- History of catheter ablation for AF
- Scheduled to receive catheter ablation for AF during the study period (next 1 year)
- Incretin-based therapy (GLP-1 receptor agonists or DPP-IV inhibitors) within 30 days prior to randomization (visit 1)
- Scheduled for bariatric surgery during the study period
- Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis
- Chronic or previous acute pancreatitis
- Current participation in any other clinical intervention trial that may result in changes to med-ical management during the study period
- Women of childbearing potential who are not on an acceptable form of contraception
- Pregnant or breastfeeding women
- Personal or family history of medullary thyroid carcinoma (MTC)
- History of MEN2 (Multiple Endocrine Neoplasia type 2)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Intervention
Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA), aiming for >10% weight loss on top of standard care.
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Weight loss period (0-16 weeks): Behavioural support (first step): Dietician-guided lifestyle vhanges through virtual meeting, frequency by patient's choice; energy intake 1500 kcal/day; <30% carbohydrates, >=60 g protein/day, adeqaute fiber, 2-2.5 L/day non-caloric fluids. Escalation strategy (second step): Meal replacement: available free of charge Pharmacotherapy: Semaglutide once weekly subcutaneous injection Target weight loss >10%; aiming for a 1% weight loss per week during the weight loss period. Weight loss maintenance period (17-52 weeks): Maintenance of >10% weigth loss Further lifestyle changes, meal replacement, or dose adjustment of weight loss medication |
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Outro: Control
Standard care, including cardiovascular risk factor management, with visit frequency and follow-up similar to the intervention group.
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Guideline-directed cardiovascular risk factor management, including medical treatment and lifestyle counseling.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hierarchical composite outcome capturing AF progression and AF burden, inte-grating clinical events assessed by blinded adjudication and objective measures of AF burden, assessed by 14-day continuous ECG monitoring
Prazo: From 4 months to 12 months after enrollment
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The hierarchical components of the primary outcome are:
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From 4 months to 12 months after enrollment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Axel Brandes, M.D., Esbjerg Hospital - University Hospital of Southern Denmark
- Investigador principal: Eva Prescott, PhD, University Hospital Bispebjerg and Frederiksberg
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças cardiovasculares
- Processos Patológicos
- Distúrbios Nutricionais
- Doenças cardíacas
- Supernutrição
- Peso corporal
- Arritmias Cardíacas
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Fibrilação atrial
- Efeitos fisiológicos das drogas
- Agentes hipoglicemiantes
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Terapêutica
- Ações farmacológicas
- Ações e usos químicos
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Agonistas do receptor do peptídeo 1 semelhante ao glucagon
- Padrão de atendimento
- Terapia medicamentosa
Outros números de identificação do estudo
- S-20260028
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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