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

NCT04704440 | Completed

• 1 other identifier: 2020-02163_A5
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension, Pulmonary

Keywords

hypoxia; exercise; Sildenafil

Outcome Measures

Primary Outcomes (1)

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

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

  4 hours

Secondary Outcomes (15)

• Differences in pulmonary arterial pressure

  4 hours

• Differences in cardiac output

  4 hours

• Differences in pulmonary vascular resistance

  4 hours

• Differences in pulmonary artery wedge pressure

  4 hours

• Differences in right atrial pressure

  4 hours

Study Arms (4)

Normobaric hypoxia (FiO2 15%)

EXPERIMENTAL

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%)

Placebo-ambient air (FiO2 21%)

SHAM COMPARATOR

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%)

Normobaric hypoxia (FiO2 15%) under Sildenafil

EXPERIMENTAL

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

Placebo-ambient air (FiO2 21%) under Sildenafil

ACTIVE COMPARATOR

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

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.

Normobaric hypoxia (FiO2 15%)

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.

Placebo-ambient air (FiO2 21%)

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.

Normobaric hypoxia (FiO2 15%) under Sildenafil

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.

Placebo-ambient air (FiO2 21%) under Sildenafil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Hypoxia; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Silvia Ulrich, Prof. Dr.

  UniversityHospital Zurich, Department of Pulmonology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: February 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 6, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication of the manuscript.

Locations

CH (1)