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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04715113
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
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.
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.

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.
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.

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.
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 under Sildenafil.

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.
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 under Sildenafil.




Primary Outcome Measures :
  1. Serum levels of ferritin [ Time Frame: Baseline ]
    Analyis of serum levels of ferritin


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715113


Contacts
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Contact: Silvia Ulrich, Prof. Dr. +41442552220 silvia.ulrich@usz.ch
Contact: Saxer Stéphanie, Dr. +41442552248 stephanie.saxer@usz.ch

Locations
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Switzerland
University Hospital of Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Silvia o Ulrich, Prof. Dr.    +41442552220    silvia.ulrich@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Ulrich, Prof. Dr. UniversityHospital Zurich, Department of Pulmonology
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04715113    
Other Study ID Numbers: 2020-02163_A4
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share individual participant data after publication of the manuscript. The decision about the platform is ongoing.
Time Frame: After publication of the manuscript

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
hypoxia
exercise
blood markers
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Hypoxia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents