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Clinical Trials/NCT04697862
NCT04697862CompletedNot Applicable

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

University of Zurich2 sites in 1 country24 target enrollmentStarted: February 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
mean pulmonary artery pressure (mPAP) / cardiac output (CO)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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

Time Frame: 4 hours

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

Secondary Outcomes

  • Differences in cardiac output(4 hours)
  • Differences in pulmonary vascular resistance(4 hours)
  • Differences in pulmonary artery wedge pressure(4 hours)
  • Differences in blood pressure(4 hours)
  • Differences in mixed venous oxygen saturation(4 hours)
  • Differences in oxygen saturation(4 hours)
  • Differences in mixed venous blood gases(4 hours)
  • Differences in pulmonary arterial pressure(4 hours)
  • Differences in right atrial pressure(4 hours)
  • Differences in heart rate(4 hours)
  • Differences in arterial blood gases(4 hours)
  • Differences in cerebral tissue oxygenation(4 hours)
  • Differences in symptoms (Borg dyspnoea)(4 hours)
  • Differences in muscle tissue oxygenation(4 hours)
  • Differences in symptoms (Borg leg effort)(4 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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