Blood Markers Predict Effect of Normobaric Hypoxia at Rest and During Exercise in Patients With Pulmonary Hypertension (HEXABM)

University of Zurich (UZH)

Status: Completed

Conditions: Hypertension, Pulmonary

Treatments: Other: Normobaric hypoxia (FiO2 15%) under Sildenafil; Other: Placebo-ambient air (FiO2 21%); Other: Placebo-ambient air (FiO2 21%) under Sildenafil; Other: Normobaric hypoxia (FiO2 15%)

Study type: Interventional

Funder types: Other

Identifiers

NCT04715113

2020-02163_A4

Details and patient eligibility

About

To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH).

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 4 patient groups

Normobaric hypoxia (FiO2 15%)

Experimental group

Description:

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.

Treatment:

Other: Normobaric hypoxia (FiO2 15%)

Placebo-ambient air (FiO2 21%)

Sham Comparator group

Description:

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.

Treatment:

Other: Placebo-ambient air (FiO2 21%)

Normobaric hypoxia (FiO2 15%) under Sildenafil

Experimental group

Description:

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.

Treatment:

Other: Normobaric hypoxia (FiO2 15%) under Sildenafil

Placebo-ambient air (FiO2 21%) under Sildenafil

Active Comparator group

Description:

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.

Treatment:

Other: Placebo-ambient air (FiO2 21%) under Sildenafil