The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
18 de março de 2018 atualizado por: Mehran Attari, University of Cincinnati
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
Visão geral do estudo
Status
Retirado
Condições
Intervenção / Tratamento
Descrição detalhada
Subjects with reduced ejection fraction will be randomized to 8 weeks Yoga training (1 in class session and home practice) vs. no Yoga.
They will undergo holter monitoring, cardiac device interrogation, and I-123 mIBG imaging at the beginning and end of the study.
Tipo de estudo
Intervencional
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Negative pregnancy test in females
- Ejection Fraction </= 40% assessed by echocardiogram within the last 12 months
- Stable dose of heart failure medications including afterload reducing medication such as ACE-I, ARB and hydralazine; beta blockers; digoxin and aldosterone antagonist for at least 4 months and no anticipated changes for 8 weeks. (i.e. no greater than a 50% dose change within the past month)
- Has an implantable pacemaker or ICD
- NYHA II-IV
Exclusion Criteria:
- pregnant or lactating female
- females without a pregnancy test
- co-administration of a positive inotrope (i.e. milrinone or dobutamine)
- history of significant medical non-compliance
- unwilling to adhere to the protocol
- Orthopedic limitation making yoga participation difficult
- Underlying cardiac rhythm other than sinus rhythm
- Recent history within 6 months prior to enrollment of unstable coronary artery disease (unstable angina, recent heart attack, recent revascularization, or decompensated heart failure)
- implantation of a cardiac resynchronization therapy device in the past 3 months.
- TIA, CVA, or major surgery in the past 3 months
- iodine or adreview (123-MIBG) allergy
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: No yoga training
This will be the control arm.
The patients in this arm will not receive any yoga training.
They will be continued on all their home, guideline-directed heart failure medications.
They will undergo the same baseline and study completion evaluation as the treatment arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
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|
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Experimental: Yoga training
The patients in this arm will receive yoga training.
This includes weekly group yoga sessions consisting of breathing exercises, yoga poses, and relaxation and meditation lasting for about 80-90 minutes total.
Patients will be asked to do home yoga practices at least twice a week and to document the date and time.
Patients in this arm will have the same baseline and study completion evaluation as the control arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
|
Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
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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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Cardiac sympathetic activity following yoga training
Prazo: 8 weeks
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A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.
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8 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
Prazo: 8 weeks
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Association between heart to mediastinum ration and ventricular arrhythmia burden
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8 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mehran Attari, University of Cincinnati
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de setembro de 2017
Conclusão Primária (Real)
27 de outubro de 2017
Conclusão do estudo (Real)
27 de outubro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
20 de julho de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de julho de 2017
Primeira postagem (Real)
24 de julho de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de março de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de março de 2018
Última verificação
1 de março de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2015-7643
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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