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

Primary Purpose

Hypertension, Pulmonary

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Normobaric hypoxia (FiO2 15%)

Placebo-ambient air (FiO2 21%)

Normobaric hypoxia (FiO2 15%) under Sildenafil

Placebo-ambient air (FiO2 21%) under Sildenafil

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring hypoxia, exercise, blood markers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Active Comparator

Arm Label

Normobaric hypoxia (FiO2 15%)

Placebo-ambient air (FiO2 21%)

Normobaric hypoxia (FiO2 15%) under Sildenafil

Placebo-ambient air (FiO2 21%) under Sildenafil

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Serum levels of ferritin

Analyis of serum levels of ferritin

Secondary Outcome Measures

Serum levels of transferrin

Analyis of serum levels of transferrin

Serum levels of total iron

Analysis of serum levels of total iron

Serum levels of erythropoietin

Analysis of serum levels of erythropoietin

Serum levels of Erythroferrone

Analysis of serum levels of erythroferrone

Serum levels of hepcidin

Analysis of serum levels of hepcidin

micro-RNA levels

Analysis of micro-RNA levels

Full Information

NCT ID

NCT04715113

First Posted

December 20, 2020

Last Updated

June 5, 2023

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT04715113

Brief Title

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

Acronym

HEXABM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

May 31, 2023 (Actual)

Study Completion Date

May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Pulmonary

Keywords

hypoxia, exercise, blood markers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normobaric hypoxia (FiO2 15%)

Arm Type

Experimental

Arm 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.

Arm Title

Placebo-ambient air (FiO2 21%)

Arm Type

Sham Comparator

Arm 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.

Arm Title

Normobaric hypoxia (FiO2 15%) under Sildenafil

Arm Type

Experimental

Arm 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.

Arm Title

Placebo-ambient air (FiO2 21%) under Sildenafil

Arm Type

Active Comparator

Arm 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.

Intervention Type

Other

Intervention Name(s)

Normobaric hypoxia (FiO2 15%)

Intervention 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.

Intervention Type

Other

Intervention Name(s)

Placebo-ambient air (FiO2 21%)

Intervention 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.

Intervention Type

Other

Intervention Name(s)

Normobaric hypoxia (FiO2 15%) under Sildenafil

Intervention 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 under Sildenafil.

Intervention Type

Other

Intervention Name(s)

Placebo-ambient air (FiO2 21%) under Sildenafil

Intervention 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 under Sildenafil.

Primary Outcome Measure Information:

Title

Serum levels of ferritin

Description

Analyis of serum levels of ferritin

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Serum levels of transferrin

Description

Analyis of serum levels of transferrin

Time Frame

Baseline

Title

Serum levels of total iron

Description

Analysis of serum levels of total iron

Time Frame

Baseline

Title

Serum levels of erythropoietin

Description

Analysis of serum levels of erythropoietin

Time Frame

Baseline

Title

Serum levels of Erythroferrone

Description

Analysis of serum levels of erythroferrone

Time Frame

Baseline

Title

Serum levels of hepcidin

Description

Analysis of serum levels of hepcidin

Time Frame

Baseline

Title

micro-RNA levels

Description

Analysis of micro-RNA levels

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Silvia Ulrich, Prof. Dr.

Organizational Affiliation

UniversityHospital Zurich, Department of Pulmonology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will share individual participant data after publication of the manuscript. The decision about the platform is ongoing.

IPD Sharing Time Frame

After publication of the manuscript

Learn more about this trial

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

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