## Protocol Section
### Identification Module
**NCT ID:** NCT03592979

**Brief Title:** Acute Exposure of Simulated Hypoxia on Heart Rate and Ventilation During Exercise

**Official Title:** Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise

#### Organization Study ID Info
**ID:** 2018-00455_A7
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### Status Module
#### Completion Date
**Date:** 2019-04-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-01-07

**Type:** ACTUAL

**Last Update Submit Date:** 2020-01-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2018-07-01

**Type:** ACTUAL

**Status Verified Date:** 2020-01

#### Study First Post Date
**Date:** 2018-07-19
**Type:** ACTUAL
**Study First Submit Date:** 2018-07-09
**Study First Submit QC Date:** 2018-07-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Zurich

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on heart rate and Ventilation changes under exercise.

**Detailed Description:** Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise.

Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.

During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants' heart rate and Ventilation will be compared under exercise.

### Conditions Module

**Conditions:**

- Pulmonary Hypertension

**Keywords:**

- Simulated altitude

- exercise

- ventilation

- heart rate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Including a baseline assessment and assessments under simulated altitude and normoxia

##### Masking Info

**Masking:** SINGLE

**Masking Description:** The allocated gas mixture will not be disclosed to the patient since he will breath trough a facemask during both interventions.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The participants will be consecutively exposed to shamed hypoxia (FiO2: 20.9%) equivalent to sea level and to simulated altitude (FiO2: 15.1%) equivalent to 2500m above sea level administered by an altitude simulator ("Altitrainer, SMTEC") with a facemask.

**Intervention Names:**

- Device: Simulated Altitude: (FiO2: 15.1)

- Device: Shamed Hypoxia (FiO2: 20.9)

**Label:** Order A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The participants will be consecutively exposed to hypoxia (FiO2: 15,1%) equivalent to 2500m above sea level and to shamed hypoxia (FiO2: 20.9%) equivalent to sea level administered by an altitude simulated ("Altitrainer, SMTEC") with a facemask.

**Intervention Names:**

- Device: Simulated Altitude: (FiO2: 15.1)

- Device: Shamed Hypoxia (FiO2: 20.9)

**Label:** Order B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Order A

- Order B

**Description:** Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.

**Name:** Simulated Altitude: (FiO2: 15.1)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Order A

- Order B

**Description:** Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.

**Name:** Shamed Hypoxia (FiO2: 20.9)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in heart rate under exercise during the exposure to simulated altitude (FiO2: 15,1%) and normoxia.

**Measure:** heart rate under exercise

**Time Frame:** 1 hour

#### Secondary Outcomes

**Description:** Change in Ventilation under exercise during the exposure to simulated altitude

**Measure:** Ventilation under exercise

**Time Frame:** 1 hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting partial oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Zurich

**Country:** Switzerland

**Facility:** Respiratory Clinic, University Hospital of Zurich

**Zip:** 8091

#### Overall Officials

**Official 1:**

**Affiliation:** University of Zurich

**Name:** Silvia Ulrich, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M4185

- Name: Hypoxia

- Relevance: HIGH

- As Found: Hypoxia

- ID: M10027

- Name: Hypertension, Pulmonary

- Relevance: HIGH

- As Found: Pulmonary Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006976

- Term: Hypertension, Pulmonary

- ID: D000006973

- Term: Hypertension

- ID: D000000860

- Term: Hypoxia

### Misc Info Module

- Version Holder: 2024-05-24
