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Completed

NCT Number: NCT04715113

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

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).

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Key information

Conditions

Hypertension, Pulmonary Behavior Cardiovascular Diseases Hypertension Hypoxia Lung Diseases Motor Activity Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Serum levels of ferritin

    Time frame: Baseline

    Analyis of serum levels of ferritin

Secondary outcomes

  1. Serum levels of transferrin

    Time frame: Baseline

    Analyis of serum levels of transferrin

  2. Serum levels of total iron

    Time frame: Baseline

    Analysis of serum levels of total iron

  3. Serum levels of erythropoietin

    Time frame: Baseline

    Analysis of serum levels of erythropoietin

  4. Serum levels of Erythroferrone

    Time frame: Baseline

    Analysis of serum levels of erythroferrone

  5. Serum levels of hepcidin

    Time frame: Baseline

    Analysis of serum levels of hepcidin

  6. micro-RNA levels

    Time frame: Baseline

    Analysis of micro-RNA levels

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial

Acronym: HEXABM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2021
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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