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

Not Applicable

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: 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

• Registration Number: NCT04715113
• Lead Sponsor: University of Zurich

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Study Start: 2021-02-01
• Status Verified: 2022-05
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normobaric hypoxia (FiO2 15%)	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.
Placebo-ambient air (FiO2 21%)	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.
Normobaric hypoxia (FiO2 15%) under Sildenafil	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.
Placebo-ambient air (FiO2 21%) under Sildenafil	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.

Primary Outcome Measures

Name	Time	Method
Serum levels of ferritin	Baseline	Analyis of serum levels of ferritin

Secondary Outcome Measures

Name	Time	Method
Serum levels of total iron	Baseline	Analysis of serum levels of total iron
Serum levels of hepcidin	Baseline	Analysis of serum levels of hepcidin
Serum levels of transferrin	Baseline	Analyis of serum levels of transferrin
Serum levels of erythropoietin	Baseline	Analysis of serum levels of erythropoietin
Serum levels of Erythroferrone	Baseline	Analysis of serum levels of erythroferrone
micro-RNA levels	Baseline	Analysis of micro-RNA levels

Trial Locations

Locations (1)

University Hospital of Zurich; 🇨🇭 Zurich, Switzerland