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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04704440
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Zurich
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Silvia Ulrich, Prof. Dr.
Principal Investigator Affiliation UniversityHospital Zurich, Department of Pulmonology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary
Arms & Interventions

Arms

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.

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.

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.

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.

Interventions

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.

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.

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.

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.

Contact a Trial Team

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International Sites

University Hospital of Zurich, Zurich, Switzerland

Status

Recruiting

Address

University Hospital of Zurich

Zurich, , 8091

Site Contact

Silvia Ulrich, Prof. Dr.

silvia.ulrich@usz.ch

+41442552220

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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