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

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ClinicalTrials.gov Identifier: NCT04704440
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension with/without Sildenafil

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Other: Normobaric hypoxia (FiO2 15%) Other: Placebo-ambient air (FiO2 21%) Other: Normobaric hypoxia (FiO2 15%) under Sildenafil Other: Placebo-ambient air (FiO2 21%) under Sildenafil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Sham Comparator: 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.
 Other: 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.
Experimental: 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.
 Other: 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.
Active Comparator: 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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704440


Contacts
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Contact: Silvia Ulrich, Prof. Dr. +41442552220 silvia.ulrich@usz.ch
Contact: Saxer Stéphanie, Dr. +41442552248 stephanie.saxer@usz.ch

Locations
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Switzerland
University Hospital of Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Silvia Ulrich, Prof. Dr.    +41442552220    silvia.ulrich@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Ulrich, Prof. Dr. UniversityHospital Zurich, Department of Pulmonology
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04704440    
Other Study ID Numbers: 2020-02163_A5
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share individual participant data after publication of the manuscript. The decision about the platform is ongoing.
Time Frame: After publication of the manuscript.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
hypoxia
exercise
Sildenafil
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Hypoxia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents