Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures
Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures.
The investigators are interested in studying how Pulmonary Hypertension occurs. A substance called 'apelin', that naturally occurs in the body has been shown to have an important role in heart disease. Previous studies have shown that it can make blood vessels get wider, and help blood flow around the body and thus improve the way the heart and lungs work.
The investigators are looking to recruit both healthy and COPD pulmonary hypertension patients to study 3 types of apelin. The purpose of this study is to help the investigators understand how Pulmonary Hypertension occurs which may will help with the development of future treatments.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The purpose of this study:
To investigate the physiological role of apelin in the cardiovascular system in patients with COPD with raised pulmonary artery pressures.
Study Aim and hypotheses:
The primary objective is to test the above hypotheses using forearm blood flow and systemic infusions of apelin peptides.
Hypotheses:
- Apelin agonists are vasodilators in human resistance vessels and this effect will be altered in patients with pulmonary hypertension.
- Apelin peptides improve right ventricular and pulmonary haemodynamics in patients with elevated pulmonary artery pressures.
Study 1a - A validation dose study of 3 apelin agonists performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 1b- A validation dose study of apelin receptor antagonist, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 2a - To define the haemodynamic response to apelin agonists in healthy volunteers and evaluate the response.
Study 2b - To investigate the haemodynamic response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Cambridge, Reino Unido, CB2 0QQ
- Vascular Research Unit, Clinical Pharmacology Unit, ACCI, Level 3, Addenbrooke's Hospital, Hills Road
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Healthy volunteers
- Aged 18 to 70 years
- Non-smoker (<1 cigarette per week)
- If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test COPD patients with estimated Pulmonary Artery Pressure (PAP) on echo >25mmHg
- Clinical diagnosis of COPD as per standard criteria
- Between 18 and 70 years
- If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test
Exclusion Criteria:
pre-existing:
- Systemic Hypertension (sustained BP >160/100mmHg)
- Ischaemic Heart Disease
- Primary valvular heart disease
- Significant left ventricular failure
- Active malignancy
- Renal disease (Creatinine >180 µmol/L)
- Neurological disease
- Diabetes mellitus
- BMI >35, BMI <17
- Pregnancy
- Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study.
- Current involvement in other research studies, other than observational/non-interventional
- Known HIV
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Systemic Apelin infusion
Study 2a - Haemodynamic studies to investigate the response to systemic infusions of 3 apelin agonists in healthy volunteers Study 2b - Haemodynamic studies to investigate the response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures |
Dose response study
Outros nomes:
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Experimental: Apelin infusion - forearm
Study 1a - A validation dose study of 3 apelin agonists using forearm plethysmography to evaluate changes in forearm blood flow: performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures. Study 1b- A validation dose study of apelin receptor antagonist using forearm plethysmography to evaluate changes in forearm blood flow, in healthy volunteers and COPD patients with elevated pulmonary artery pressures. |
Dose response study
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Percentage change in forearm blood flow in the infused arm. Forearm blood flow ratio in each arm, blood pressure and heart rate will also be reported.
Prazo: 12 months
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12 months
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Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate.
Prazo: 12 months
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12 months
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Outras medidas de resultado
Medida de resultado |
Prazo |
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Exploratory endpoints in Study 2 are systolic and diastolic blood pressure.
Prazo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dr. Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
Outros números de identificação do estudo
- ALPHa-COPD
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