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

NCT04715113 | Completed

• 1 other identifier: 2020-02163_A4
• 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 on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH).

Conditions

Hypertension, Pulmonary

Keywords

hypoxia; exercise; blood markers

Outcome Measures

Primary Outcomes (1)

• Serum levels of ferritin

  Analyis of serum levels of ferritin

  Baseline

Secondary Outcomes (6)

• Serum levels of transferrin

  Baseline

• Serum levels of total iron

  Baseline

• Serum levels of erythropoietin

  Baseline

• Serum levels of Erythroferrone

  Baseline

• Serum levels of hepcidin

  Baseline

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 under Sildenafil.

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 under Sildenafil.

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: December 20, 2020
• First Posted: January 20, 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)