Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension With/Without Sildenafil

Hypertension, Pulmonary Clinical Trial

— HEXAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704440
• Other study ID #: 2020-02163_A5
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension with/without Sildenafil

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Hypoxia

Intervention

Other:
• Normobaric hypoxia (FiO2 15%)
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
• Placebo-ambient air (FiO2 21%)
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.
• Normobaric hypoxia (FiO2 15%) under Sildenafil
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
• Placebo-ambient air (FiO2 21%) under Sildenafil
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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean pulmonary artery pressure (mPAP) / cardiac output (CO)	Difference in mPAP/CO during exercise between tests under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in pulmonary arterial pressure	Differences in pulmonary arterial pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in cardiac output	Differences in cardiac output at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in pulmonary vascular resistance	Differences in pulmonary vascular resistance at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in pulmonary artery wedge pressure	Differences in pulmonary artery wedge pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in right atrial pressure	Differences in right atrial pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in mixed venous oxygen saturation	Differences in mixed venous oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in heart rate	Differences in heart rate at rest and during exercise, under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in blood pressure	Differences in blood pressure at rest and during exercise, under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in oxygen saturation	Differences in oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in arterial blood gases	Differences in arterial blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in mixed venous blood gases	Differences in mixed venous blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in cerebral tissue oxygenation	Differences in cerebral tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in muscle tissue oxygenation	Differences in muscle tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in symptoms (Borg dyspnoea)	Differences in symptoms (Borg dyspnoea) at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours
Secondary	Differences in symptoms (Borg leg effort)	Differences in symptoms (Borg leg effort) at rest and during exercise under normoxia/hypoxia with/without Sildenafil	4 hours