## Protocol Section
### Identification Module
**NCT ID:** NCT03637179

**Brief Title:** Acute Exposure to High Altitude on Pulmonary Artery Pressure and Right Heart Function (Echo) Under 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_B4
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### Status Module
#### Completion Date
**Date:** 2019-01-01

**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:** 2019-01-01

**Type:** ACTUAL

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

**Type:** ACTUAL

**Status Verified Date:** 2020-01

#### Study First Post Date
**Date:** 2018-08-17
**Type:** ACTUAL
**Study First Submit Date:** 2018-07-09
**Study First Submit QC Date:** 2018-08-16
### 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 High Altitude (2500m above sea level) on pulmonary artery pressure and right heart function (Echo) under exercise.

**Detailed Description:** Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo under exercise.

### Conditions Module

**Conditions:**

- Pulmonary Hypertension

**Keywords:**

- High Altitude

- Pulmonary artery pressure

- Echocardiography

- Right heart function

- exercise

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Crossover Assignment Including a baseline assessment and assessments at Low altitude and High altitude

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)

**Intervention Names:**

- Other: Assessment at Low Altitude (470m above sea level)

- Other: Exposure to High Altitude (2500m above sea level)

**Label:** Order A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).

**Intervention Names:**

- Other: Assessment at Low Altitude (470m above sea level)

- Other: Exposure to High Altitude (2500m above sea level)

**Label:** Order B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Order A

- Order B

**Description:** Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

**Name:** Assessment at Low Altitude (470m above sea level)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Order A

- Order B

**Description:** Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

**Name:** Exposure to High Altitude (2500m above sea level)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Pulmonary artery pressure will be measured by echo (TTE) under exercise.

**Measure:** Echocardiographic Assessment at High Altitude (2500m) during exercise

**Time Frame:** 1 day at altitude

#### Secondary Outcomes

**Description:** The right heart function (fac, D-Shaping, etc.) will be assessed by echocardiography (TTE) under exercise

**Measure:** Echocardiographic right heart assessment at High Altitude (2500m) during exercise

**Time Frame:** 1 day at altitude

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a 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 PaO2 ≤7.3 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, 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

### 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: LOW

- As Found: Unknown

- 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: 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

### Misc Info Module

- Version Holder: 2024-05-24
