Hemodynamic Effects During Exercise in Patients With Pulmonary Hypertension Receiving Sildenafil

Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial

Patrocinadores

Patrocinador principal: University of Zurich

Fuente University of Zurich
Resumen breve

To study hemodynamic effects of Sildenafil during exercise in patients with pulmonary hypertension.

Estado general Not yet recruiting
Fecha de inicio February 1, 2021
Fecha de Terminación December 31, 2024
Fecha de finalización primaria December 31, 2023
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
mean pulmonary artery pressure (mPAP) / cardiac output (CO) 4 hours
Resultado secundario
Medida Periodo de tiempo
Differences in pulmonary arterial pressure 4 hours
Differences in cardiac output 4 hours
Differences in pulmonary vascular resistance 4 hours
Differences in pulmonary artery wedge pressure 4 hours
Differences in right atrial pressure 4 hours
Differences in mixed venous oxygen saturation 4 hours
Differences in heart rate 4 hours
Differences in blood pressure (systolic and diastolic) 4 hours
Differences in oxygen saturation 4 hours
Differences in arterial blood gases 4 hours
Differences in mixed venous blood gases 4 hours
Differences in cerebral tissue oxygenation 4 hours
Differences in muscle tissue oxygenation 4 hours
Differences in symptoms (Borg dyspnoea) 4 hours
Differences in symptoms (leg effort) 4 hours
Inscripción 24
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Hemodynamic effect of exercise under Sildenafil

Descripción: Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under SIldenafil.

Etiqueta de grupo de brazo: Hemodynamic effect of exercise under Sildenafil

Tipo de intervención: Other

Nombre de intervención: Hemodynamic effect of exercise

Descripción: Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Etiqueta de grupo de brazo: Hemodynamic effect of exercise

Elegibilidad

Criterios:

Inclusion Criteria: - Informed consent as documented by signature (Appendix Informed Consent Form) - PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization Exclusion Criteria: - resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air - exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study - inability to follow the procedures of the study - patients who take nitrates - other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Silvia Ulrich, Prof. Dr. Principal Investigator UniversityHospital Zurich, Department of Pulmonology
Contacto general

Apellido: Silvia Ulrich, Prof. Dr.

Teléfono: +41442552220

Email: [email protected]

Ubicación
Instalaciones: UniversityHospital Zurich, Department of Pulmonology
Ubicacion Paises

Switzerland

Fecha de verificación

January 2021

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Hemodynamic effect of exercise under Sildenafil

Tipo: Experimental

Descripción: Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under SIldenafil.

Etiqueta: Hemodynamic effect of exercise

Tipo: Other

Descripción: Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Acrónimo HEXASN
Datos del paciente Yes
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Other

Enmascaramiento: Single (Participant)

Fuente: ClinicalTrials.gov