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Completed

NCT Number: NCT04704440

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

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

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Key information

Conditions

Hypertension, Pulmonary Behavior Cardiovascular Diseases Hypertension Hypoxia Lung Diseases Motor Activity Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 Sildenafil

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%) under Sildenafil

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.

Primary outcomes

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

    Time frame: 4 hours

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

Secondary outcomes

  1. Differences in pulmonary arterial pressure

    Time frame: 4 hours

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

  2. Differences in cardiac output

    Time frame: 4 hours

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

  3. Differences in pulmonary vascular resistance

    Time frame: 4 hours

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

  4. Differences in pulmonary artery wedge pressure

    Time frame: 4 hours

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

  5. Differences in right atrial pressure

    Time frame: 4 hours

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

  6. Differences in mixed venous oxygen saturation

    Time frame: 4 hours

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

  7. Differences in heart rate

    Time frame: 4 hours

    Differences in heart rate at rest and during exercise, under normoxia/hypoxia with/without Sildenafil

  8. Differences in blood pressure

    Time frame: 4 hours

    Differences in blood pressure at rest and during exercise, under normoxia/hypoxia with/without Sildenafil

  9. Differences in oxygen saturation

    Time frame: 4 hours

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

  10. Differences in arterial blood gases

    Time frame: 4 hours

    Differences in arterial blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil

  11. Differences in mixed venous blood gases

    Time frame: 4 hours

    Differences in mixed venous blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil

  12. Differences in cerebral tissue oxygenation

    Time frame: 4 hours

    Differences in cerebral tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil

  13. Differences in muscle tissue oxygenation

    Time frame: 4 hours

    Differences in muscle tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil

  14. Differences in symptoms (Borg dyspnoea)

    Time frame: 4 hours

    Differences in symptoms (Borg dyspnoea) at rest and during exercise under normoxia/hypoxia with/without Sildenafil

  15. Differences in symptoms (Borg leg effort)

    Time frame: 4 hours

    Differences in symptoms (Borg leg effort) at rest and during exercise under normoxia/hypoxia with/without Sildenafil

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: HEXAS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2021
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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