Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension Receiving Sildenafil

NCT ID: NCT04697862

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-05-31

Brief Summary

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

Conditions

Hypertension, Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 under Sildenafil.

Group Type: EXPERIMENTAL

Normobaric hypoxia (FiO2 15%) under Sildenafil

Intervention Type: OTHER

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 under Sildenafil.

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.

Group Type: EXPERIMENTAL

Normobaric hypoxia (FiO2 15%)

Intervention Type: OTHER

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.

Interventions

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 under Sildenafil.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

UniversityHospital Zurich, Department of Pulmonology

Locations

UniversityHospital Zurich, Department of Pulmonology

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2020-02163_A3

Identifier Type: -

Identifier Source: org_study_id