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

University of Zurich24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypertension, Pulmonary

Interventions

Normobaric hypoxia (FiO2 15%) under SildenafilOTHER

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%)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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

UniversityHospital Zurich, Department of Pulmonology

Zurich, Switzerland

Outcomes

Primary Outcomes

mean pulmonary artery pressure (mPAP) / cardiac output (CO)

Difference in mPAP/CO during exercise between tests under normoxia with/without Sildenafil

Time frame: 4 hours

Secondary Outcomes

Differences in pulmonary arterial pressure

Differences in pulmonary arterial pressure at rest and during exercise with/without Sildenafil

Time frame: 4 hours

Differences in cardiac output

Differences in cardiac output at rest and during exercise with/without Sildenafil

Time frame: 4 hours

Differences in pulmonary vascular resistance

Differences in pulmonary vascular resistance at rest and during exercise with/without Sildenafil

Time frame: 4 hours

Differences in pulmonary artery wedge pressure

Differences in pulmonary artery wedge pressure at rest and during exercise with/without Sildenafil

Time frame: 4 hours

Differences in right atrial pressure

Differences in right atrial pressure at rest and during exercise with/without Sildenafil

Time frame: 4 hours

Differences in mixed venous oxygen saturation

Differences in mixed venous oxygen saturation at rest and during exercise with/without Sildenafil

Time frame: 4 hours

Differences in heart rate

Differences in heart rate at rest and during exercise with/without Sildenafil

Data from ClinicalTrials.gov

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