Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension With/Without 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%)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.

Placebo-ambient air (FiO2 21%)OTHER

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 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.

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)

University Hospital of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

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

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

Time frame: 4 hours

Secondary Outcomes

Differences in pulmonary arterial pressure

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

Time frame: 4 hours

Differences in cardiac output

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

Time frame: 4 hours

Differences in pulmonary vascular resistance

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

Time frame: 4 hours

Differences in pulmonary artery wedge pressure

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

Time frame: 4 hours

Differences in right atrial pressure

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

Time frame: 4 hours

Differences in mixed venous oxygen saturation

Differences in mixed venous oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil

Time frame: 4 hours

Data from ClinicalTrials.gov

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