Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH
31 августа 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
20
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Silvia Ulrich, Prof. Dr. med.
- Номер телефона: +41442552220
- Электронная почта: silvia.ulrich@usz.ch
Учебное резервное копирование контактов
- Имя: Michael Furian, Prof. Dr. sc. ETH
- Номер телефона: +41442552220
Места учебы
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Zurich, Швейцария, 8091
- University Hospital of Zurich
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
FEV1 after re-ascent to 2850m
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Forced Vital Capacity FVC after re-ascent to 2850m
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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)
|
|
Respiratory reactance (forced oscillation technique) after re-ascent to 2850m
Временное ограничение: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
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)
|
|
Respiratory resistance (forced oscillation technique) after 4 days at sea level
Временное ограничение: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
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)
|
|
Respiratory reactance (forced oscillation technique) after 4 days at sea level
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
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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FEV1/FVC pre-descent and after re-ascent (2850m)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Главный следователь: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
25 сентября 2026 г.
Первичное завершение (Оцененный)
4 октября 2026 г.
Завершение исследования (Оцененный)
31 декабря 2026 г.
Даты регистрации исследования
Первый отправленный
17 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
31 августа 2026 г.
Первый опубликованный (Действительный)
4 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
31 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Ec_LAvsHA_Lufu_PAH
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .