Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH
31 de agosto de 2026 atualizado por: Silvia Ulrich Somaini
Effect of a One-week Descent From 2850m to Sea Level and Re-ascent in Patients With Pulmonary Arterial Hypertension and Healthy Controls Permanently Living > 2600m on Pulmonary Hemodynamics, Exercise Capacity, Blood Oxygenation, Sleep Disordered Breathing and Further Outcomes
To study the effect of a re-ascent to high altitude (Quito Ecuador: 2850m) after a one-week stay at sea level (after prior descent from 2850m) on lung function and pulmonary resistance/reactance in patients with pulmonary arterial disease PAH, who live permanently > 2600m.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
The aim of this research is to investigate the lung function and pulmonary resistance/reactance before and after re-ascent (sea level for 7 days after prior descent from 2850m vs. re-ascent to 2850m) in patients with diagnosed pulmonary hypertension according to guidelines, who permanently live at high altitude over 2600m.
Tipo de estudo
Intervencional
Inscrição (Estimado)
20
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.
Contato de estudo
- Nome: Silvia Ulrich, Prof. Dr. med.
- Número de telefone: +41442552220
- E-mail: silvia.ulrich@usz.ch
Estude backup de contato
- Nome: Michael Furian, Prof. Dr. sc. ETH
- Número de telefone: +41442552220
Locais de estudo
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Zurich, Suíça, 8091
- University Hospital of Zurich
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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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Adult patients aged 18-80 years and of all genders
- Permanent residence > 2600 m
- Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines
- Patients are stable on therapy
- NYHA (new york heart association) functional class I-III.
- written informed consent to participate in the study.
Exclusion Criteria:
- Age <18 years or >80 years
- unstable condition
- Patients who cannot follow the study investigations
- Patient permanently living < 2600m.
- Patients who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
- Severely hypoxemic patients at Quito permanently having persistent SpO2 (oxygen saturation by pulseoximetry) <80% on ambient air.
- Patient with a non-corrected ventricular septum defect
- Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Lung function at sea level and at 2850m
Assessment of lung function and pulmonary resistance/reactance on day four at sea level (after prior descent from 2850m) and after re-ascent (after totally one week at sea level) back to 2850m by bus (in one day)
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Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m
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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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FEV1 after re-ascent to 2850m
Prazo: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in forced expiratory volume in one second FEV1 between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Forced Vital Capacity FVC after re-ascent to 2850m
Prazo: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in forced vital capacity FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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FEV1/FVC after re-ascent to 2850m
Prazo: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in FEV1/FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m
Prazo: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in respiratory impedance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Respiratory resistance (forced oscillation technique) after re-ascent to 2850m
Prazo: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in respiratory resistance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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Respiratory reactance (forced oscillation technique) after re-ascent to 2850m
Prazo: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in respiratory reactance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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FEV1 after 4 days at sea level
Prazo: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Forced Vital Capacity FVC after 4 days at sea level
Prazo: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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FEV1/FVC after 4 days at sea level
Prazo: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Respiratory Impedance (forced oscillation technique) after 4 days at sea level
Prazo: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in respiratory impedance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Respiratory resistance (forced oscillation technique) after 4 days at sea level
Prazo: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in respiratory resistance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
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Respiratory reactance (forced oscillation technique) after 4 days at sea level
Prazo: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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FEV1 pre-descent and after re-ascent (2850m)
Prazo: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
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Difference/change in FEV1 at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial disease
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Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
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Forced Vital Capacity FVC pre-descent and after re-ascent (2850m)
Prazo: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in forced vital capacity FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
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Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
FEV1/FVC pre-descent and after re-ascent (2850m)
Prazo: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in FEV1/FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory Impedance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Prazo: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory impedance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory resistance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Prazo: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory resistance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory reactance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Prazo: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory reactance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Investigador principal: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
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 (Estimado)
25 de setembro de 2026
Conclusão Primária (Estimado)
4 de outubro de 2026
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
17 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de agosto de 2026
Primeira postagem (Real)
4 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Ec_LAvsHA_Lufu_PAH
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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